Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-19 @ 3:45 AM
Study NCT ID:
NCT02988466
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow 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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'juck0001@umn.edu', 'phone': '(612) 626-5654', 'title': 'Mark Juckett, MD', 'organization': 'University of Minnesota, Masonic Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 10, 'seriousNumAtRisk': 14, 'deathsNumAffected': 6, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 11, 'seriousNumAtRisk': 21, 'deathsNumAffected': 13, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 5, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 15, 'seriousNumAtRisk': 35, 'deathsNumAffected': 18, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Fungal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 27, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Fungal Infection'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 95, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 152, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 43, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 67, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Viral Infection'}], 'seriousEvents': [{'term': 'Serious bacterial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 56, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 133, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 36, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 109, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells'}, {'id': 'OG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '78'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '48'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '67'}, {'value': '57', 'groupId': 'OG003', 'lowerLimit': '39', 'upperLimit': '72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells'}, {'id': 'OG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)'}], 'classes': [{'title': 'grade II-IV acute graft versus-host-disease (GVHD)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '42'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '54'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '31', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '47'}]}]}, {'title': 'grade III-IV acute graft versus-host-disease (GVHD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '36'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '22'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 100', 'description': 'Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Related Mortality (TRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells'}, {'id': 'OG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)'}], 'classes': [{'title': 'TRM 6 months', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '42'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '75'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '13', 'upperLimit': '38'}]}]}, {'title': 'TRM 1 year', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '42'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '79'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '11', 'upperLimit': '40'}]}]}, {'title': 'TRM 2 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '42'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '81'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '27', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '42'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month, 1 and 2 year', 'description': 'Percentage of participants experiencing treatment related mortality (TRM).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relapse Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells'}, {'id': 'OG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)'}], 'classes': [{'title': 'Relapse Incidence 1 year', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '52'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '46'}, {'value': '75', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': '100'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '11', 'upperLimit': '40'}]}]}, {'title': 'Relapse Incidence 2 year', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '52'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '49'}, {'value': '75', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '100'}, {'value': '28', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '43'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 and 2 year', 'description': 'Percentage of participants experiencing a relapse incidence at 1 and 2 years.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Serious Fungal and Viral Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'OG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells'}, {'id': 'OG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)'}], 'classes': [{'title': 'Day 100', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '60'}, {'value': '6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '13'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '69'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '22'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at day 100 and 1 year', 'description': 'Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'FG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'FG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells'}, {'id': 'FG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Haplo-HCT <55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2\n\nHaplo HCT \\<55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'BG001', 'title': 'CLOSED Arm B: Haplo-HCT ≥55 Years Old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nHaplo HCT ≥55 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)'}, {'id': 'BG002', 'title': 'Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥55 and \\< 65 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells'}, {'id': 'BG003', 'title': 'Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.\n\nGVHD Prophylaxis: - Cyclophosphamide (Cy)\n\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)\n\nHaplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu)\n\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', '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': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-11', 'size': 841398, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-11T09:18', 'hasProtocol': True}, {'date': '2024-03-11', 'size': 10848061, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-11T09:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2016-12-07', 'resultsFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-13', 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival (DFS)', 'timeFrame': '1 year', 'description': 'Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant'}], 'secondaryOutcomes': [{'measure': 'Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)', 'timeFrame': 'day 100', 'description': 'Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).'}, {'measure': 'Treatment Related Mortality (TRM)', 'timeFrame': '6 month, 1 and 2 year', 'description': 'Percentage of participants experiencing treatment related mortality (TRM).'}, {'measure': 'Relapse Incidence', 'timeFrame': '1 and 2 year', 'description': 'Percentage of participants experiencing a relapse incidence at 1 and 2 years.'}, {'measure': 'Incidence of Serious Fungal and Viral Infection', 'timeFrame': 'at day 100 and 1 year', 'description': 'Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Leukemias', 'Acute myeloid leukemia (AML)', 'Acute lymphoblastic leukemia (ALL)/lymphoma', 'Biphenotypic/Undifferentiated/Prolymphocytic Leukemias', 'Myelodysplastic syndrome', 'Chronic myelogenous leukemia', 'Minimal Residual Disease (MRD) positive leukemia', 'Leukemia or Myelodysplastic Syndromes (MDS) in aplasia', 'Myeloproliferative neoplasms/myelofibrosis', 'Relapsed large-cell lymphoma, mantle-cell lymphoma and Hodgkin lymphoma', "Burkitt's lymphoma", 'Relapsed T-cell lymphoma', 'Natural Killer cell malignancies', 'Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma', 'Lymphoplasmacytic lymphoma', 'Relapsed multiple myeloma', 'Bone marrow failure syndromes'], 'conditions': ['Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) \\>3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Karnofsky performance status of ≥70% or Lansky play score ≥ 70%\n* A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches\n* The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.\n* Adequate liver and renal function\n* Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%\n* Diffusion capacity corrected (DLCOcorr) \\> 40% predicted, and absence of O2 requirements\n* \\> 6 months after prior autologous transplant (if applicable)\n* Agrees to use contraception during study treatment\n* Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)\n* Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nExclusion Criteria:\n\n* \\< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor\n* Pregnancy or breastfeeding\n* Current active and uncontrolled serious infection\n* Acute leukemia in morphologic relapse/persistent disease defined as \\> 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.\n* stable non-bulky disease is acceptable.\n* Active central nervous system malignancy\n\nCriteria For Donor Selection:\n\n* Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.\n* Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.\n* For donors \\<18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors \\<18 years.'}, 'identificationModule': {'nctId': 'NCT02988466', 'briefTitle': 'Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies', 'orgStudyIdInfo': {'id': '2016LS092'}, 'secondaryIdInfos': [{'id': 'MT2016-15', 'type': 'OTHER', 'domain': 'University of Minnesota Blood and Marrow Transplant Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Haplo-HCT <55 years old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \\<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2', 'interventionNames': ['Biological: Haplo HCT <55 years old', 'Drug: GVHD Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'CLOSED Arm B: Haplo-HCT ≥55 years old', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.', 'interventionNames': ['Biological: Haplo HCT ≥55 years old', 'Drug: GVHD Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \\< 65 years old.', 'interventionNames': ['Drug: GVHD Prophylaxis', 'Biological: Haplo HCT ≥55 and < 65 years old']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3', 'description': 'Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.', 'interventionNames': ['Drug: GVHD Prophylaxis', 'Biological: Haplo HCT ≥65 and ≤75 years old']}], 'interventions': [{'name': 'Haplo HCT <55 years old', 'type': 'BIOLOGICAL', 'otherNames': ['HLA-haploidentical related hematopoietic cells transplant'], 'description': '* Fludarabine (Flu)\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion Day 0', 'armGroupLabels': ['Arm A: Haplo-HCT <55 years old']}, {'name': 'Haplo HCT ≥55 years old', 'type': 'BIOLOGICAL', 'otherNames': ['HLA-haploidentical related hematopoietic cells transplant'], 'description': '* Fludarabine (Flu)\n* Cyclophosphamide (Cy)\n* Melphalan (Mel): Dose reduction by 30%\n* Total body irradiation (TBI)\n* Non-T-cell depleted donor bone marrow stem cell infusion', 'armGroupLabels': ['CLOSED Arm B: Haplo-HCT ≥55 years old']}, {'name': 'GVHD Prophylaxis', 'type': 'DRUG', 'description': '* Cyclophosphamide (Cy)\n* Tacrolimus (Tac)\n* Mycophenolate mofetil (MMF)', 'armGroupLabels': ['Arm A: Haplo-HCT <55 years old', 'Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo', 'Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3', 'CLOSED Arm B: Haplo-HCT ≥55 years old']}, {'name': 'Haplo HCT ≥55 and < 65 years old', 'type': 'BIOLOGICAL', 'otherNames': ['HLA-haploidentical related hematopoietic cells transplant'], 'description': '* Fludarabine (Flu)\n* Cyclophosphamide (Cy)\n* Melphalan (Mel)\n* Total body irradiation (TBI)\n* non-T-cell depleted donor bone marrow stem cells', 'armGroupLabels': ['Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo']}, {'name': 'Haplo HCT ≥65 and ≤75 years old', 'type': 'BIOLOGICAL', 'otherNames': ['HLA-haploidentical related hematopoietic cells transplant'], 'description': '* Fludarabine (Flu)\n* Cyclophosphamide (Cy)\n* Total body irradiation (TBI)', 'armGroupLabels': ['Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center at University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Najla El Jurdi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}