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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 4:35 PM

Ignite Modification Date: 2025-12-26 @ 2:54 AM

Study NCT ID: NCT01119066

Status: COMPLETED

Last Update Posted: 2022-08-05

First Post: 2010-05-04

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'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': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D013852', 'term': 'Thiotepa'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D000077866', 'term': 'Clofarabine'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013721', 'term': 'Triethylenephosphoramide'}, {'id': 'D001388', 'term': 'Aziridines'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oreillyr@MSKCC.ORG', 'phone': '646-888-2157', 'title': "Richard O'Reilly, MD", 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years', 'description': 'Please note: participants were not censored from adverse event evaluation if they had a second or third transplant on protocol', 'eventGroups': [{'id': 'EG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 120, 'otherNumAffected': 16, 'seriousNumAtRisk': 125, 'deathsNumAffected': 42, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant', 'otherNumAtRisk': 213, 'deathsNumAtRisk': 210, 'otherNumAffected': 31, 'seriousNumAtRisk': 213, 'deathsNumAffected': 71, 'seriousNumAffected': 30}, {'id': 'EG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 47, 'otherNumAffected': 9, 'seriousNumAtRisk': 52, 'deathsNumAffected': 18, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'deathsNumAffected': 3, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CMV Viremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gen disorders & admin site conditions Other, spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin & subcutaneous tissue disorders Other, spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gen disorders & admin site conditions Other, spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin & subcutaneous tissue disorders Other, spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'title': 'Engrafted', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Primary Graft Failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Late graft failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Not Evaluable Engraftment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'title': 'aGVHD II-IV', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'cGVHD, Limited', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'cGVHD, Extensive', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Standard BMT-CTN and IBMTR systems clinical criteria as defined by Rowlings, et al will be used to establish and grade acute GvHD. Chronic GvHD will be diagnosed and graded according to the criteria of Sullivan (CIBMTR).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'title': 'Alive', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Dead (not non-relapse mortality)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dead (non-relapse mortality)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.'}, {'type': 'PRIMARY', 'title': 'Survival and Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'title': 'Survival', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '92.4', 'groupId': 'OG001'}, {'value': '87.2', 'groupId': 'OG002'}, {'value': '90.9', 'groupId': 'OG003'}]}]}, {'title': 'Disease Free Survival', 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000'}, {'value': '89.0', 'groupId': 'OG001'}, {'value': '85.1', 'groupId': 'OG002'}, {'value': '90.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 6 months post transplant', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients received 2 separate transplants on each Arm A and C'}, {'type': 'PRIMARY', 'title': 'Survival and Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'title': 'Survival', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}, {'value': '85.1', 'groupId': 'OG002'}, {'value': '81.8', 'groupId': 'OG003'}]}]}, {'title': 'Disease free survival', 'categories': [{'measurements': [{'value': '68.3', 'groupId': 'OG000'}, {'value': '73.7', 'groupId': 'OG001'}, {'value': '83.0', 'groupId': 'OG002'}, {'value': '72.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post transplant', 'unitOfMeasure': '% of pts at 1 year post transplant', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients received 2 separate transplants on each Arm A and C'}, {'type': 'PRIMARY', 'title': 'Survival and Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'title': 'Survival', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000'}, {'value': '72.1', 'groupId': 'OG001'}, {'value': '63.8', 'groupId': 'OG002'}, {'value': '71.6', 'groupId': 'OG003'}]}]}, {'title': 'Disease Free Survival', 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}, {'value': '59.6', 'groupId': 'OG002'}, {'value': '62.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years post transplant', 'unitOfMeasure': '% of pts at 2 years', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients received 2 separate transplants on each Arm A and C'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Receiving Optimal CD3+ (<1x10^5/kg) Cell Doses the Proportion of Patients Receiving CD3+ T-cell Doses > 1x10^5/kg.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'categories': [{'title': 'CD3 Optimal', 'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'CD3 Suboptimal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients received 2 separate transplants on each Arm A and C. Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Receiving Optimal CD34+ (> 5x10^6/kg) Cell Doses the Proportion Recurring Suboptimal Doses (< 2x10^6/kg) CD34+ Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'categories': [{'title': 'Optimal', 'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Suboptimal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'None', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.'}, {'type': 'SECONDARY', 'title': 'Correlation of Doses of CD34+ Progenitors and CD3+ T Cells With Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'OG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'classes': [{'categories': [{'title': 'Optimal (> 5x106/kg), Engrafted', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Optimal (> 5x106/kg), Late Graft Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Optimal (> 5x106/kg), Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Suboptimal(< 2x106/kg), Engrafted', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Suboptimal(< 2x106/kg), Late Graft Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Suboptimal(< 2x106/kg), Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Other(2-5X106/kg), Engrafted', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Other(2-5X106/kg), Late Graft Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Other(2-5X106/kg), Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'FG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'FG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'FG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '132'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '227'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '52'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '125'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '213'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '52'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '7'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '14'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Concern regarding adequacy of transplant cell dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Relapse identified before transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Intercurrent medication condition rendered patient ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Relapse identified before transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Additional Transplant', 'preAssignmentDetails': '2 patients received 2 separate transplants on each Arm A and C'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '401', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)\n\ntotal body irradiation: dose of 1375-1500 cGy\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nCyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'BG001', 'title': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)\n\nBusulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics\n\nMelphalan: 70mg/m2/day x 2\n\nFludarabine: 25mg/m2/ day x 5\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'BG002', 'title': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\nClofarabine: 20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'BG003', 'title': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)\n\nThiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1\n\nMelphalan: 70mg/m2/day x 2\n\n(CliniMACS) T-cell depleted PBSC Transplant'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'BG000', 'lowerLimit': '3.5', 'upperLimit': '63.9'}, {'value': '57.6', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '73'}, {'value': '28.1', 'groupId': 'BG002', 'lowerLimit': '0.6', 'upperLimit': '67.2'}, {'value': '10', 'groupId': 'BG003', 'lowerLimit': '0.8', 'upperLimit': '67.2'}, {'value': '48', 'groupId': 'BG004', 'lowerLimit': '0.6', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '244', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '317', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '401', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-21', 'size': 1508425, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-31T13:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2010-05-04', 'resultsFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2010-05-05', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-11', 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.', 'timeFrame': '3 years'}, {'measure': 'Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System.', 'timeFrame': '3 years', 'description': 'Standard BMT-CTN and IBMTR systems clinical criteria as defined by Rowlings, et al will be used to establish and grade acute GvHD. Chronic GvHD will be diagnosed and graded according to the criteria of Sullivan (CIBMTR).'}, {'measure': 'Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System.', 'timeFrame': '3 years'}, {'measure': 'Survival and Disease-free Survival (DFS)', 'timeFrame': 'at 6 months post transplant'}, {'measure': 'Survival and Disease-free Survival (DFS)', 'timeFrame': '1 year post transplant'}, {'measure': 'Survival and Disease-free Survival (DFS)', 'timeFrame': '2 years post transplant'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Receiving Optimal CD3+ (<1x10^5/kg) Cell Doses the Proportion of Patients Receiving CD3+ T-cell Doses > 1x10^5/kg.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Proportion of Patients Receiving Optimal CD34+ (> 5x10^6/kg) Cell Doses the Proportion Recurring Suboptimal Doses (< 2x10^6/kg) CD34+ Cells', 'timeFrame': '3 years'}, {'measure': 'Correlation of Doses of CD34+ Progenitors and CD3+ T Cells With Engraftment', 'timeFrame': '3 years'}]}, 'conditionsModule': {'keywords': ['Leukemia', 'Multiple Myeloma', 'radiation', 'Thiotepa', 'cyclophosphamide', 'fludarabine', 'Clofarabine', 'CliniMACS device', 'GCSF', '10-050'], 'conditions': ['Acute Lymphoblastic Leukemia', 'Acute Myelogenous Leukemia', 'Myelodysplastic Syndrome', 'Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out the effects of using a system called CliniMACS to remove Tcells from blood stem cells. Removing T-cells may help stop a side effect called Graft-Versus-Host Disease (GVHD). Some studies have been done with CliniMACS, but the Food and Drug Administration (FDA) has not yet approved it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Malignant conditions or other life threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:\n* AML in 1st remission - for patients whose AML does not have 'good risk' cytogenetic features (i.e. t 8;21, t15;17, inv 16).\n* Secondary AML in 1st remission\n* AML in 1st relapse or \\> than or = to 2nd remission\n* ALL/CLL in 1st remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL \\> than or = to 2nd remission\n* CML failing to respond to or not tolerating Imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase second chronic phase or in CR after accelerated phase or blast crisis.\n* Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories:\n\n 1. intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.\n 2. any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.\n* Myelodysplastic syndrome (MDS): RA//RARS/RCMD with high risk cytogenetic features or transfusion dependence as well as RAEB-1 and RAEB-2 and Acute myelogenous leukemia (AML) evolved from MDS, who are not eligible for transplantation and/or unable to enroll onto protocol IRB 08-008.\n* Chronic myelomonocytic leukemia: CMML-1 and CMML-2.\n* Multiple Myeloma with disease in the following categories:\n\n 1. Patients with relapsed multiple myeloma following autologous stem cell transplantation who have achieved at least partial response following additional chemotherapy.\n 2. Patients with high risk cytogenetics at diagnosis must have achieved a partial response following autologous stem cell transplantation. Patients must have complex karyotype, del17p, t4;14 and/or t14;16 by FISH and/or del13 by karyotyping.\n* Other rare lethal disorders of Hematopoiesis and Lymphopoiesis for which a T-cell depleted transplant is indicated (e.g. hemophagocytic lymphohistiocytosis; refractory aplastic anemia or congenital cytopenias; non-SCID lethal genetic immunodeficiencies such as Wiskott Aldrich Syndrome, CD40 ligand deficiency, or ALPS, as well as refractory autoimmune cytopenias, PNH, metabolic storage diseases or heavily transfused congenital hemoglobinopathies).\n* Accrual to each treatment arm will include up to 30 standard risk and 30 poor risk patients (60 patients/treatment arm) except for Regimen D, which will include 30 patients/treatment arm, all of which will be poor risk by virtue of risks of relapse and/or transplant related mortality.\n* Standard risk patients will include eligible patients, as defined above, who are receiving transplants as treatment for MDS in RA//RARS/RCMD, AML in 1st or 2nd remission, ALL in 1st CR, NHL in 1st remission, MM in 1st remission, Very Good Partial Response, or 1st Partial Response or CML in the first chronic phase or 1st remission.\n* All other patients, including those with treatment related malignancies and/or those who have AML derived from MDS, will have received extensive prior chemo/radiotherapy and, therefore, will be considered to be at poor risk of conditioning and transplant related morbidities, and potentially transplant related mortality. Patients with life threatening non-malignant genetic and acquired disorders will also, by virtue of their history of, optional transfusions and/or infection be considered poor risk. Stopping rules for non-relapse related mortality in these heavily treated patients are, therefore, slightly less stringent than patients in the poor risk transplant groups. Stopping rules for the principal endpoints of graft failure and GvHD are the same for all groups.\n\nThe following inclusion criteria are also required:\n\n* Patient's age includes from birth on to \\< 70 years old.\n* Patients may be of either gender or any ethnic background.\n* Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \\> or = to 70%\n* Patients must have adequate organ function measured by:\n\nCardiac: asymptomatic or if symptomatic then LVEF at rest must be \\> or = to 50% and must improve with exercise.\n\nHepatic: \\< 3x ULN AST and ≤ to 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease are also eligible with PI approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders.\n\nRenal: serum creatinine \\< than or = to 1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl \\> 40 ml/min (measured or calculated/estimated) Pulmonary: asymptomatic or if symptomatic, DLCO \\> or = to 50% of predicted (corrected for hemoglobin)\n\n* Each patient must be willing to participate as a research subject and must sign an informed consent form.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast-feeding\n* Active viral, bacterial or fungal infection\n* Patient seropositive for HIV-I/II; HTLV -I/II\n* Presence of leukemia in the CNS.\n\nDonor Inclusion Criteria:\n\n* Each donor must meet criteria outlined by institutional guidelines\n* Donor should agree to undergo general anesthesia and bone marrow harvest collection if PBSC yield is inadequate or otherwise not transplantable for whatever reason.\n\nDonor Exclusion Criteria\n\n* If donors do not meet institutional guidelines, exclusion will be considered."}, 'identificationModule': {'nctId': 'NCT01119066', 'briefTitle': 'HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase II Trial of Transplants From HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies and Other Lethal Hematologic Disorders', 'orgStudyIdInfo': {'id': '10-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total Body Irradiation, Thiotepa and Cyclophosphamide', 'description': 'Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)', 'interventionNames': ['Radiation: total body irradiation', 'Drug: Thiotepa', 'Drug: Cyclophosphamide', 'Procedure: (CliniMACS) T-cell depleted PBSC Transplant']}, {'type': 'EXPERIMENTAL', 'label': 'Busulfan, Melphalan and Fludarabine', 'description': 'Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)', 'interventionNames': ['Drug: Busulfan', 'Drug: Melphalan', 'Drug: Fludarabine', 'Procedure: (CliniMACS) T-cell depleted PBSC Transplant']}, {'type': 'EXPERIMENTAL', 'label': 'Clofarabine, Melphalan and Thiotepa', 'description': 'Clofarabine (20mg/m2/ day x 5) (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)', 'interventionNames': ['Drug: Thiotepa', 'Drug: Melphalan', 'Drug: Clofarabine', 'Procedure: (CliniMACS) T-cell depleted PBSC Transplant']}, {'type': 'EXPERIMENTAL', 'label': 'Melphalan, Fludarabine and Thiotepa', 'description': 'Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)', 'interventionNames': ['Drug: Thiotepa', 'Drug: Melphalan', 'Procedure: (CliniMACS) T-cell depleted PBSC Transplant']}], 'interventions': [{'name': 'total body irradiation', 'type': 'RADIATION', 'description': 'dose of 1375-1500 cGy', 'armGroupLabels': ['Total Body Irradiation, Thiotepa and Cyclophosphamide']}, {'name': 'Thiotepa', 'type': 'DRUG', 'description': '5 mg/kg/day x 2 or 10 mg/kg/day x 1', 'armGroupLabels': ['Clofarabine, Melphalan and Thiotepa', 'Melphalan, Fludarabine and Thiotepa', 'Total Body Irradiation, Thiotepa and Cyclophosphamide']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).', 'armGroupLabels': ['Total Body Irradiation, Thiotepa and Cyclophosphamide']}, {'name': 'Busulfan', 'type': 'DRUG', 'description': '0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics', 'armGroupLabels': ['Busulfan, Melphalan and Fludarabine']}, {'name': 'Melphalan', 'type': 'DRUG', 'description': '70mg/m2/day x 2', 'armGroupLabels': ['Busulfan, Melphalan and Fludarabine', 'Clofarabine, Melphalan and Thiotepa', 'Melphalan, Fludarabine and Thiotepa']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': '25mg/m2/ day x 5', 'armGroupLabels': ['Busulfan, Melphalan and Fludarabine']}, {'name': 'Clofarabine', 'type': 'DRUG', 'description': '20mg/m2/ day x 5 (or, for children \\<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)', 'armGroupLabels': ['Clofarabine, Melphalan and Thiotepa']}, {'name': '(CliniMACS) T-cell depleted PBSC Transplant', 'type': 'PROCEDURE', 'armGroupLabels': ['Busulfan, Melphalan and Fludarabine', 'Clofarabine, Melphalan and Thiotepa', 'Melphalan, Fludarabine and Thiotepa', 'Total Body Irradiation, Thiotepa and Cyclophosphamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': "Richard O'Reilly, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}