Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-27 @ 7:14 PM
Study NCT ID:
NCT00119366
Status:
TERMINATED
Last Update Posted:
2022-12-12
First Post:
2005-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jorozco@fredhutch.org', 'phone': '(206) 667-4102', 'title': 'Johnnie Orozco, MD, PhD', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': "Serious adverse events and Other (not including serious adverse events) were monitored and recorded from the time of first exposure to the investigational product (i.e. Iodine 131 + BC8 mAB) through day +100 post-transplant or through patient discharge from the Seattle Cancer Care Alliance (SCCA) system to the patient's primary physician. All-Cause Mortality was monitored/assessed for up to 2 years or through participant survival after completing the study regimen and transplant.", 'eventGroups': [{'id': 'EG000', 'title': 'Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 2, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'notes': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'notes': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hearing loss', 'notes': 'Hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'notes': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'notes': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'notes': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'WBC', 'notes': 'WBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'notes': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pericardial effusion', 'notes': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'notes': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'notes': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/chills', 'notes': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash/desquamation', 'notes': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot flashes/flushes', 'notes': 'Hot flashes/flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thyroid function, high (hyperthyroidism, thyrotoxicosis)', 'notes': 'Thyroid function, high (hyperthyroidism, thyrotoxicosis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'notes': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysguesia', 'notes': 'Dysguesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis', 'notes': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'notes': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'notes': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, GU Vagina', 'notes': 'Hemorrhage, GU Vagina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bacteremia', 'notes': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Blood infection - Ralstonia pickettii', 'notes': 'Blood infection - Ralstonia pickettii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe', 'notes': 'Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC \\<1.0 x 10e9/L, fever \\>=38.5 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils Blood', 'notes': 'Infection with normal ANC or Grade 1 or 2 neutrophils Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Coagulase negative staph', 'notes': 'Coagulase negative staph', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC Oral cavity-gums (gingivitis)', 'notes': 'Thrush/candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC Upper airway NOS', 'notes': 'Rhinovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC Upper airway NOS', 'notes': 'Infection with unknown ANC Upper airway NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC Upper airway NOS', 'notes': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema: limb', 'notes': 'Lower Extremity Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphatics - Other (Fluid overload)', 'notes': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'notes': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'notes': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'notes': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Magnesium, serum-low (hypomagnesemia)', 'notes': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'notes': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle weakness', 'notes': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anxiety', 'notes': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry eye syndrome', 'notes': 'Dry eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Keratitis (corneal inflammation/corneal ulceration)', 'notes': 'Keratitis (corneal inflammation/corneal ulceration)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain Chest/thorax NOS', 'notes': 'Pain Chest/thorax NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Myalgia', 'notes': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'notes': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'notes': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'notes': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pleural effusion (non-malignant)', 'notes': 'Pleural effusion (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Keratitis', 'notes': 'Corneal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Engraftment Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular and nodal arrhythmia', 'notes': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'notes': 'Low blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia', 'notes': 'Difficulty swallowing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe', 'notes': 'Neutropenic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - Other (Pulmonary Aspirgillus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - Other (C. Difficile)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology- Other (altered mental status)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Extremity/Limb (Left shoulder)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ARDS', 'notes': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-limiting Toxicities (DLT) 100 Days After Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG002', 'title': 'Dose Level 8: 24 Gy Iodine-131 + BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG003', 'title': 'Dose Level 9: 26 Gy Iodine-131 + BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG004', 'title': 'Dose Level 10: 28 Gy Iodine-131 + BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'title': 'Number of participants with no dose-limiting toxicities 100 days after transplant', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'Number of participants with dose-limiting toxicities 100 days after transplant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 100 days post-transplant', 'description': 'The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows:\n\nGrade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible.\n\nGrade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies.\n\nGrade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants that received and completed study treatment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Transplant Related Mortality Within 100 Days After Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG002', 'title': 'Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG003', 'title': 'Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG004', 'title': 'Dose Level 10: 28 Gy Iodine-131+ BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}], 'classes': [{'categories': [{'title': 'Number of participants who died within 100 days after transplant', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Number of participants who are alive > 100 days after transplant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 100 days post-transplant', 'description': 'Number of participants that received and completed study treatment who died within 100 days after transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that received and completed study treatment who died within 100 days after transplant'}, {'type': 'SECONDARY', 'title': 'Participant Disease Response Within 4 Weeks After Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG002', 'title': 'Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG003', 'title': 'Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG004', 'title': 'Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'title': 'Number of participants that are in CR 4 weeks after transplant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Number of participants that relapsed 4 weeks after transplant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks after transplant', 'description': 'The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant.\n\nComplete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following:\n\n* Normal bone marrow with blasts \\<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.\n* Normalization of blood counts (no blasts, platelets \\>100,000/mm3, granulocytes \\>1,500/mm3).\n* No extramedullary disease.\n\nRelapse is measured as follows:\n\n* After CR: \\>5% blasts in the bone marrow and/or peripheral blood.\n* Confirmation of relapse by bone marrow analysis with more than 10% blasts.\n* Extramedullary disease confirmed cytologically or histologically.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that received and completed study treatment'}, {'type': 'SECONDARY', 'title': 'Severity of Acute GVHD in Patients Who Completed the Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG002', 'title': 'Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG003', 'title': 'Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG004', 'title': 'Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'title': 'Number of participants with Grade 0-1 GVHD', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Number of participants with Grade 2 GVHD', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Number of participants with Grade 3 GVHD', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days after transplant', 'description': 'The severity of acute GVHD is measured based on Graft-vs-Host Disease:\n\nSeverity of GVHD Grade I +1 to +2 skin rash No gut or liver involvement\n\nGrade II +3 skin rash or\n\n* 1 gastrointestinal involvement and/or +1 liver involvement\n\nGrade III +2 to +4 gastrointestinal involvement and/or\n\n* 2 to +4 liver involvement with or without a rash\n\nGrade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants that completed study treatment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 100% Donor Chimerism at Day 28 and Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG002', 'title': 'Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG003', 'title': 'Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG004', 'title': 'Dose Level 10: 28 Gy Iodine-131+ BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}], 'classes': [{'title': 'Day 28 Donor Chimerism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Day 84 Donor Chimerism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28 and Day 80 after transplant', 'description': 'Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that completed the study regimen'}, {'type': 'SECONDARY', 'title': 'Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG002', 'title': 'Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG003', 'title': 'Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}, {'id': 'OG004', 'title': 'Dose Level 10: 28 Gy Iodine-131+ BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studie'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years post transplant', 'description': 'Survival and complete resolution of all signs of leukemia for 2 years after transplant with all of the following:\n\n1. Normal bone marrow with blasts \\<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.\n2. Normalization of blood counts (no blasts, platelets \\>100,000/mm3, granulocytes \\>1,500/mm3).\n3. No extramedullary disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who are alive and disease-free 2 years after transplant'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'FG001', 'title': 'Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'FG002', 'title': 'Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'FG003', 'title': 'Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'FG004', 'title': 'Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eighteen participants enrolled in the study:\n\n16 - received \\& completed study treatment\n\n02 - withdrawn from the study', 'preAssignmentDetails': 'Dose escalation plan: single patients will be entered on the first stage, and escalation by 2 Gy increments in the radiation dose delivered to the normal organ receiving the highest dose will occur until a patient experiences a Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT), at which point the second stage will begin at the next lower dose level. If the first patient (i.e., at the starting dose level) has DLT, de-escalation will occur by 2 Gy increments'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG001', 'title': 'Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG002', 'title': 'Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG003', 'title': 'Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG004', 'title': 'Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.\n\niodine I 131 monoclonal antibody BC8: Given IV\n\nfludarabine phosphate: Given IV\n\ntotal-body irradiation: Undergo TBI\n\nallogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation\n\nperipheral blood stem cell transplantation: Undergo PBSC transplantation\n\ncyclosporine: Given IV or PO\n\nmycophenolate mofetil: Given PO\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-09-17', 'size': 471479, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-02T04:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This study will assess the feasibility and safety of patients with advanced AML or high-risk MDS treated with Iodine-131 BC8 antibody at a starting dose of 22 Gy delivered to the normal organ receiving the highest dose combined with fludarabine and 2 Gy total body irradiation (TBI), plus cyclosporine (CSP)/mycophenolate mofetil (MMF), followed by matched related or unrelated allogeneic hematopoietic stem cell transplantation (HSCT). Determination of the maximum tolerated dose (MTD) will be the major study endpoint.\n\nDose-escalation/de-escalation of radiolabeled BC8 antibody (I-131-BC8) is conducted using a "two-stage" approach. Under this plan, dose levels during the first stage are increased (or decreased) for individual patients until a dose-limiting toxicity (DLT) is observed, at which point the second stage proceeds with each dose level administered to a cohort of four patients.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Funding ended before target accrual was reached; participants are no longer being examined or receiving intervention.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'dispFirstSubmitDate': '2017-04-13', 'completionDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-09', 'studyFirstSubmitDate': '2005-07-12', 'dispFirstSubmitQcDate': '2017-04-13', 'resultsFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2005-07-12', 'dispFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-07', 'studyFirstPostDateStruct': {'date': '2005-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-limiting Toxicities (DLT) 100 Days After Transplant', 'timeFrame': 'Up to 100 days post-transplant', 'description': 'The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows:\n\nGrade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible.\n\nGrade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies.\n\nGrade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Transplant Related Mortality Within 100 Days After Transplant', 'timeFrame': 'Up to 100 days post-transplant', 'description': 'Number of participants that received and completed study treatment who died within 100 days after transplant'}, {'measure': 'Participant Disease Response Within 4 Weeks After Transplant', 'timeFrame': '4 weeks after transplant', 'description': 'The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant.\n\nComplete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following:\n\n* Normal bone marrow with blasts \\<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.\n* Normalization of blood counts (no blasts, platelets \\>100,000/mm3, granulocytes \\>1,500/mm3).\n* No extramedullary disease.\n\nRelapse is measured as follows:\n\n* After CR: \\>5% blasts in the bone marrow and/or peripheral blood.\n* Confirmation of relapse by bone marrow analysis with more than 10% blasts.\n* Extramedullary disease confirmed cytologically or histologically.'}, {'measure': 'Severity of Acute GVHD in Patients Who Completed the Study Treatment', 'timeFrame': '100 days after transplant', 'description': 'The severity of acute GVHD is measured based on Graft-vs-Host Disease:\n\nSeverity of GVHD Grade I +1 to +2 skin rash No gut or liver involvement\n\nGrade II +3 skin rash or\n\n* 1 gastrointestinal involvement and/or +1 liver involvement\n\nGrade III +2 to +4 gastrointestinal involvement and/or\n\n* 2 to +4 liver involvement with or without a rash\n\nGrade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death'}, {'measure': 'Number of Participants With 100% Donor Chimerism at Day 28 and Day 84', 'timeFrame': 'Day 28 and Day 80 after transplant', 'description': 'Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis'}, {'measure': 'Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen', 'timeFrame': '2 years post transplant', 'description': 'Survival and complete resolution of all signs of leukemia for 2 years after transplant with all of the following:\n\n1. Normal bone marrow with blasts \\<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.\n2. Normalization of blood counts (no blasts, platelets \\>100,000/mm3, granulocytes \\>1,500/mm3).\n3. No extramedullary disease.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities', 'Adult Acute Myeloid Leukemia With Del(5q)', 'Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)', 'Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)', 'Childhood Myelodysplastic Syndromes', 'Chronic Myelomonocytic Leukemia', 'Previously Treated Myelodysplastic Syndromes', 'Recurrent Adult Acute Myeloid Leukemia', 'Recurrent Childhood Acute Myeloid Leukemia', 'Refractory Anemia With Excess Blasts', 'Refractory Anemia With Excess Blasts in Transformation', 'Refractory Anemia With Ringed Sideroblasts', 'Refractory Cytopenia With Multilineage Dysplasia', 'Secondary Acute Myeloid Leukemia', 'Secondary Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': "This phase II trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute myeloid leukemia or myelodysplastic syndromes.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the maximum tolerated dose (MTD) and the transplant-related mortality (TRM) and toxicity of delivering 131I-BC8 (iodine I 131 monoclonal antibody BC8) (anti-cluster of differentiation \\[CD\\]45 antibody) at a starting dose of 22 Gy to the normal organ receiving the highest dose in combination with the non-myeloablative regimen of fludarabine (fludarabine phosphate) (FLU), 2 Gy total body irradiation (TBI), cyclosporine (CSP), mycophenolate mofetil (MMF), and human leukocyte antigen (HLA)-matched related or unrelated allogeneic hematopoietic stem cell transplant (HSCT) in patients 16 to 50 years old who have advanced acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS).\n\nII. To estimate rates of donor chimerism resulting from this combined preparative regimen and to correlate level of donor chimerism with estimated radiation doses delivered to hematopoietic tissues via antibody.\n\nIII. To determine rates of disease relapse, graft vs. host disease, and 2-year disease-free survival in patients receiving 131I-BC8 antibody combined with FLU, 2 Gy TBI, CSP, MMF, and HLA-matched related or unrelated allogeneic HSCT.\n\nOUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody BC8.\n\nRADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 intravenously (IV) on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic peripheral blood stem cell (PBSC) transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or orally (PO) twice daily (BID) on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO thrice daily (TID) on days 0 to 40 followed by a taper to day 96.\n\nAfter completion of study treatment, patients are followed up at 6, 9, 12, 18, and 24 months and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced AML defined as beyond first remission, primary refractory disease, or evolved from myelodysplastic or myeloproliferative syndromes; or patients with MDS expressed as refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEBT), refractory cytopenia with multilineage dysplasia (RCMD), RCMD with ringed sideroblasts (RCMD-RS), or chronic myelomonocytic leukemia (CMML)\n* Patients not in remission must have CD45-expressing leukemic blasts or myelodysplastic cells; patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow)\n* Patients should have a circulating blast count of less than 10,000/mm\\^3 (control with hydroxyurea or similar agent is allowed)\n* Patients must have an estimated creatinine clearance greater than 50/ml per minute (serum creatinine value must be within 28 days prior to registration)\n* Bilirubin \\< 2 times the upper limit of normal\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\< 2 times the upper limit of normal\n* Karnofsky score \\>= 70 or Eastern Cooperative Oncology Group (ECOG) =\\< 2\n* Patients must have an expected survival of \\> 60 days and must be free of active infection\n* Patients must have an HLA-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and developmentally regulated RNA binding protein 1 (DRB1) according to Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Guidelines and to the allele level at DQB1; unrelated donors should be identified using matching criteria that follows the FHCRC Standard Practice Guidelines limiting the study to eligible donors that are allele matched for HLA-A, B, C, DRB1, and DQB1 (grade 1), and accepting up to one allele mismatch as per Standard Practice grade 2.1 for HLA-A, B, or C\n* DONOR: Donors must meet HLA matching criteria as well as standard SCCA and/or NMDP or other donor center criteria for PBSC donation\n\nExclusion Criteria:\n\n* Circulating antibody against mouse immunoglobulin (human anti-mouse antibody \\[HAMA\\])\n* Prior radiation to maximally tolerated levels to any normal organ\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects\n* Inability to understand or give an informed consent\n* Patients who are seropositive for human immunodeficiency virus (HIV)\n* Perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation\n* Patients who have previously undergone autologous or allogeneic HSCT'}, 'identificationModule': {'nctId': 'NCT00119366', 'briefTitle': 'Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Phase II Trial Combining Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine and Low Dose TBI Followed by Related or Unrelated PBSC Infusion and Post-Transplant Immunosuppression for Patients With Advanced AML or High Risk Myelodysplastic Syndrome', 'orgStudyIdInfo': {'id': '1809.00'}, 'secondaryIdInfos': [{'id': 'NCI-2010-00234', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '1809.00', 'type': 'OTHER', 'domain': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.', 'interventionNames': ['Radiation: iodine I 131 monoclonal antibody BC8', 'Drug: fludarabine phosphate', 'Radiation: total-body irradiation', 'Procedure: allogeneic hematopoietic stem cell transplantation', 'Procedure: peripheral blood stem cell transplantation', 'Drug: cyclosporine', 'Drug: mycophenolate mofetil', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.', 'interventionNames': ['Radiation: iodine I 131 monoclonal antibody BC8', 'Drug: fludarabine phosphate', 'Radiation: total-body irradiation', 'Procedure: allogeneic hematopoietic stem cell transplantation', 'Procedure: peripheral blood stem cell transplantation', 'Drug: cyclosporine', 'Drug: mycophenolate mofetil', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.', 'interventionNames': ['Radiation: iodine I 131 monoclonal antibody BC8', 'Drug: fludarabine phosphate', 'Radiation: total-body irradiation', 'Procedure: allogeneic hematopoietic stem cell transplantation', 'Procedure: peripheral blood stem cell transplantation', 'Drug: cyclosporine', 'Drug: mycophenolate mofetil', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.', 'interventionNames': ['Radiation: iodine I 131 monoclonal antibody BC8', 'Drug: fludarabine phosphate', 'Radiation: total-body irradiation', 'Procedure: allogeneic hematopoietic stem cell transplantation', 'Procedure: peripheral blood stem cell transplantation', 'Drug: cyclosporine', 'Drug: mycophenolate mofetil', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'description': 'RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12.\n\nCONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.', 'interventionNames': ['Radiation: iodine I 131 monoclonal antibody BC8', 'Drug: fludarabine phosphate', 'Radiation: total-body irradiation', 'Procedure: allogeneic hematopoietic stem cell transplantation', 'Procedure: peripheral blood stem cell transplantation', 'Drug: cyclosporine', 'Drug: mycophenolate mofetil', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'iodine I 131 monoclonal antibody BC8', 'type': 'RADIATION', 'otherNames': ['I 131 MOAB BC8', 'I 131 Monoclonal Antibody BC8', 'iodine I 131 MOAB BC8'], 'description': 'Given IV', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}, {'name': 'fludarabine phosphate', 'type': 'DRUG', 'otherNames': ['2-F-ara-AMP', 'Beneflur', 'Fludara'], 'description': 'Given IV', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}, {'name': 'total-body irradiation', 'type': 'RADIATION', 'otherNames': ['TBI'], 'description': 'Undergo TBI', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}, {'name': 'allogeneic hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'description': 'Undergo PBSC transplantation', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['PBPC transplantation', 'PBSC transplantation', 'peripheral blood progenitor cell transplantation', 'transplantation, peripheral blood stem cell'], 'description': 'Undergo PBSC transplantation', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}, {'name': 'cyclosporine', 'type': 'DRUG', 'otherNames': ['ciclosporin', 'cyclosporin', 'cyclosporin A', 'CYSP', 'Sandimmune'], 'description': 'Given IV or PO', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}, {'name': 'mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['Cellcept', 'MMF'], 'description': 'Given PO', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8', 'Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Johnnie Orozco', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Johnnie Orozco', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}