Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-02 @ 7:54 AM
Study NCT ID:
NCT00119392
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2005-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System 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': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'C422802', 'term': 'ibritumomab tiuxetan'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'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'}, {'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': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'akgopal@fhcrc.org', 'phone': '206-288-2037', 'title': 'Ajay Gopal', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI', 'otherNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 40, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 27}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Elevated ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Elevated Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Decreased WBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Decreased hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Embolism Thrombosis/Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'seriousEvents': [{'term': 'Neutropenic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tumor lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Related Mortality (TRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At day +100', 'description': 'Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall and Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI'}], 'classes': [{'title': 'Overall survival', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '68'}]}]}, {'title': 'Progression free survival', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '48'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 years', 'description': 'Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Engraftment and Hematopoietic Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI'}], 'classes': [{'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '34'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '147'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At day +100', 'description': 'Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI'}], 'classes': [{'title': 'Acute GVHD: Grade 1-2', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Acute GVHD: Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Chronic extensive GVHD', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At day +84', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)', 'description': 'See Detailed Description\n\nrituximab: Given IV\n\ncyclosporine: Given orally\n\nfludarabine phosphate: Given IV\n\nmycophenolate mofetil: Given orally\n\nyttrium Y 90 ibritumomab tiuxetan: Given IV\n\nperipheral blood stem cell transplantation: Undergo transplantation\n\nallogeneic hematopoietic stem cell transplantation: Undergo transplantation\n\ntotal-body irradiation: Undergo TBI'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-01', 'studyFirstSubmitDate': '2005-07-12', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2005-07-12', 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-17', 'studyFirstPostDateStruct': {'date': '2005-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Related Mortality (TRM)', 'timeFrame': 'At day +100', 'description': 'Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.'}], 'secondaryOutcomes': [{'measure': 'Overall and Progression-free Survival', 'timeFrame': 'Up to 8 years', 'description': 'Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.'}, {'measure': 'Response Rates', 'timeFrame': 'Up to 8 years'}, {'measure': 'Engraftment and Hematopoietic Toxicity', 'timeFrame': 'At day +100', 'description': 'Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.'}, {'measure': 'Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.', 'timeFrame': 'At day +84'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['B-cell Chronic Lymphocytic Leukemia', 'Nodal Marginal Zone B-cell Lymphoma', 'Recurrent Adult Burkitt Lymphoma', 'Recurrent Adult Diffuse Large Cell Lymphoma', 'Recurrent Adult Diffuse Mixed Cell Lymphoma', 'Recurrent Adult Diffuse Small Cleaved Cell Lymphoma', 'Recurrent Adult Grade III Lymphomatoid Granulomatosis', 'Recurrent Adult Immunoblastic Large Cell Lymphoma', 'Recurrent Adult Lymphoblastic Lymphoma', 'Recurrent Grade 1 Follicular Lymphoma', 'Recurrent Grade 2 Follicular Lymphoma', 'Recurrent Grade 3 Follicular Lymphoma', 'Recurrent Mantle Cell Lymphoma', 'Recurrent Marginal Zone Lymphoma', 'Recurrent Small Lymphocytic Lymphoma', 'Splenic Marginal Zone Lymphoma', 'Waldenström Macroglobulinemia']}, 'referencesModule': {'references': [{'pmid': '30454872', 'type': 'DERIVED', 'citation': 'Puronen CE, Cassaday RD, Stevenson PA, Sandmaier BM, Flowers ME, Green DJ, Maloney DG, Storb RF, Press OW, Gopal AK. Long-Term Follow-Up of 90Y-Ibritumomab Tiuxetan, Fludarabine, and Total Body Irradiation-Based Nonmyeloablative Allogeneic Transplant Conditioning for Persistent High-Risk B Cell Lymphoma. Biol Blood Marrow Transplant. 2018 Nov;24(11):2211-2215. doi: 10.1016/j.bbmt.2018.06.033. Epub 2018 Jul 3.'}, {'pmid': '21508413', 'type': 'DERIVED', 'citation': 'Gopal AK, Guthrie KA, Rajendran J, Pagel JM, Oliveira G, Maloney DG, Matesan MC, Storb RF, Press OW. (9)(0)Y-Ibritumomab tiuxetan, fludarabine, and TBI-based nonmyeloablative allogeneic transplantation conditioning for patients with persistent high-risk B-cell lymphoma. Blood. 2011 Jul 28;118(4):1132-9. doi: 10.1182/blood-2010-12-324392. Epub 2011 Apr 20.'}]}, 'descriptionModule': {'briefSummary': "Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the feasibility, safety, and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched related or unrelated donor hematopoietic cell transplantation.\n\nOUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21. Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by, no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients also receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a taper over 11 weeks in the absence of GVHD. These patients also receive oral mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96.\n\nAfter completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a histologically confirmed diagnosis of a lymphoid malignancy expressing the cluster of differentiation (CD)20 antigen and have failed at least one prior standard systemic therapy\n* Patients must have evidence of persistent lymphoma by physical examination, radiographic studies, bone marrow evaluation, flow cytometry, or polymerase chain reaction (PCR)\n* Creatinine \\< 2.0\n* Bilirubin \\< 1.5 mg/dL\n* Patients must have an expected survival of \\> 60 days and must be free of major infection including human immunodeficiency virus (HIV)\n* Patients must have an HLA-identical related or unrelated donor\n* DONOR: Donor eligibility includes both HLA-matched relatives or HLA matched, unrelated volunteer donors; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and DRB1 according to 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 (Grade1), and accepting up to one allele mismatch as per Standard Practice Grade 2.1 for HLA-A, B, or C\n* Donor must consent to granulocyte colony-stimulating factor (G-CSF) (filgrastim) administration and leukapheresis\n* Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)\n\nExclusion Criteria:\n\n* Systemic anti-lymphoma therapy given in the previous 30 days\n* Patients who have experienced progressive disease within 3 months of prior Bexxar or Zevalin\n* Inability to understand or give an informed consent\n* Central nervous system lymphoma\n* Pregnancy\n* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment\n* Southwest Oncology Group (SWOG)/Eastern Cooperative Oncology Group (ECOG) performance score \\> 2\n* Eligible for radioimmunotherapy-based autologous transplant trial\n* Medical condition that would contraindicate allogeneic transplantation\n* Evidence of Human Anti-Mouse Antibody (HAMA) for patients with prior exposure to therapeutic murine antibodies\n* Eligible for other therapeutic options that will be more likely to have a better long-term disease-free survival with lower potential toxicity (e.g., non-transplant therapy, autologous transplants, etc.) than this study\n* Other grave medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g. unstable angina, pulmonary dysfunction \\[diffusing capacity of the lung for carbon monoxide (DLCO) \\< 30%, total lung capacity (TLC) \\< 30%, continuous supplemental oxygen\\], acquired immune deficiency syndrome \\[AIDS\\], etc.)\n* DONOR: Identical twin\n* DONOR: Age less than 12 years\n* DONOR: Pregnancy\n* DONOR: Infection with HIV\n* DONOR: Inability to achieve adequate venous access\n* DONOR: Known allergy to G-CSF\n* DONOR: Current serious systemic illness or infection'}, 'identificationModule': {'nctId': 'NCT00119392', 'briefTitle': "Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma', 'orgStudyIdInfo': {'id': '1726.00'}, 'secondaryIdInfos': [{'id': 'NCI-2010-01381', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)', 'description': 'See Detailed Description', 'interventionNames': ['Biological: rituximab', 'Drug: cyclosporine', 'Drug: fludarabine phosphate', 'Drug: mycophenolate mofetil', 'Radiation: yttrium Y 90 ibritumomab tiuxetan', 'Procedure: peripheral blood stem cell transplantation', 'Procedure: allogeneic hematopoietic stem cell transplantation', 'Radiation: total-body irradiation']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['IDEC-C2B8', 'IDEC-C2B8 monoclonal antibody', 'Mabthera', 'MOAB IDEC-C2B8', 'Rituxan'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}, {'name': 'cyclosporine', 'type': 'DRUG', 'otherNames': ['ciclosporin', 'cyclosporin', 'cyclosporin A', 'CYSP', 'Sandimmune'], 'description': 'Given orally', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}, {'name': 'fludarabine phosphate', 'type': 'DRUG', 'otherNames': ['2-F-ara-AMP', 'Beneflur', 'Fludara'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}, {'name': 'mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['Cellcept', 'MMF'], 'description': 'Given orally', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}, {'name': 'yttrium Y 90 ibritumomab tiuxetan', 'type': 'RADIATION', 'otherNames': ['90Y ibritumomab tiuxetan', 'IDEC Y2B8', 'Y90 Zevalin', 'Y90-labeled ibritumomab tiuxetan'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}, {'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 transplantation', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}, {'name': 'allogeneic hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'description': 'Undergo transplantation', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}, {'name': 'total-body irradiation', 'type': 'RADIATION', 'otherNames': ['TBI'], 'description': 'Undergo TBI', 'armGroupLabels': ['Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)']}]}, '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': 'Ajay Gopal', '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': 'Ajay Gopal', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}