Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT00568633
Status:
TERMINATED
Last Update Posted:
2019-09-24
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rlowsky@stanford.edu', 'phone': '650-725-8950', 'title': 'Robert Lowsky, Professor of Medicine (Blood and Marrow Transplantation)', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'Non-serious adverse events were not collected in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 16, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 20, 'seriousNumAffected': 24}], 'seriousEvents': [{'term': 'Relapse, leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-relapse Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transplant-related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'title': 'At 100 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At 6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days and 6 months', 'description': 'Transplant-related mortality will be assessed as any death occurring within 6 months post-transplant, from any cause except relapse. It will be measured at 100 day and 6 months after transplant. The outcome is expressed as at the number of participants experiencing transplant-related mortality (a number without dispersion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.'}, {'type': 'SECONDARY', 'title': 'Complete Donor Hematopoietic Cell Chimerism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of \\> 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.'}, {'type': 'SECONDARY', 'title': 'Early Graft Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Early graft loss means a failure to achieve donor T-cell chimerism of \\> 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.'}, {'type': 'SECONDARY', 'title': 'Patients Completing the Intended Therapy in Both Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'OG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '81.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'FG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28\n\nAllogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.\n\nAnti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV\n\nCyclosporine (CSP): 6.25 mg/kg twice daily oral\n\nMycophenolate mofetil (MMF): 15 mg/kg twice daily oral\n\nTotal lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.\n\nMethylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV'}, {'id': 'BG001', 'title': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation\n\nBest standard care: Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '60', 'spread': '6', 'groupId': 'BG001'}, {'value': '60', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatment assignment was based on availability of an HLA-matched donor.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2007-12-04', 'resultsFirstSubmitDate': '2019-08-16', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-16', 'studyFirstPostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion).'}], 'secondaryOutcomes': [{'measure': 'Disease-free Survival (DFS)', 'timeFrame': '2 years', 'description': 'Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion).'}, {'measure': 'Non-relapse Mortality', 'timeFrame': '2 years', 'description': 'Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion).'}, {'measure': 'Relapse Rate', 'timeFrame': '2 years', 'description': 'Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion).'}, {'measure': 'Transplant-related Mortality', 'timeFrame': '100 days and 6 months', 'description': 'Transplant-related mortality will be assessed as any death occurring within 6 months post-transplant, from any cause except relapse. It will be measured at 100 day and 6 months after transplant. The outcome is expressed as at the number of participants experiencing transplant-related mortality (a number without dispersion).'}, {'measure': 'Complete Donor Hematopoietic Cell Chimerism', 'timeFrame': '2 years', 'description': 'Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of \\> 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion.'}, {'measure': 'Early Graft Loss', 'timeFrame': '2 years', 'description': 'Early graft loss means a failure to achieve donor T-cell chimerism of \\> 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion.'}, {'measure': 'Patients Completing the Intended Therapy in Both Arms', 'timeFrame': '2 years', 'description': 'The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia, Myeloid', 'Leukemia', 'Acute Myeloid Leukemia (AML)']}, 'descriptionModule': {'briefSummary': 'Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* ≥ 50 years of age and ≤ 75 years of age.\n* De novo acute myelogenous leukemia (AML), based on FAB and WHO criteria.\n* Intermediate or unfavorable cytogenetic abnormalities based on Southwest Oncology Group (SWOG) Cytogenetic Criteria.\n* First morphologic complete remission (CR), or CRp (a complete remission but with low platelets) following 1 or 2 courses of induction therapy, documented no more than 8 weeks prior to the date of enrollment and confirmed at time of enrollment.\n* Karnofsky Performance Score ≥ 60.\n* Suitable for non-myeloablative transplantation or best treatment.\n* Able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\n* AML with favorable cytogenetic features based on SWOG Cytogenetic Criteria\n* AML, either treatment-related or MDS-related\n* Active CNS disease as identified by positive CSF cytospin at time of enrollment.\n* Prior or concurrent malignancies except localized non-melanoma skin malignancies or treated cervical carcinoma in situ. (EXCEPTION: Cancer treated with curative intent \\> 5 years previously is allowed. EXCEPTION: Low grade lymphoma is allowed as long as active treatment is not required for control of disease)\n* Planned for allogeneic transplant using a full-dose conditioning\n* Life expectancy \\< 1 year due to diseases other than malignancy\n* Pregnant or breastfeeding.\n* HIV-seropositive.\n* Uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month.\n* Symptomatic coronary artery disease or uncontrolled congestive heart failure. Left ventricular ejection fraction (LVEF) is not required to be measured, however if measured, exclusion if ejection fraction is \\< 30%.\n* Requiring supplementary continuous oxygen. Diffusing capacity of the lungs for carbon monoxide (DLCO) is not required to be measured, however if it is measured, exclusion if DLCO \\< 35%.\n* Fulminant liver failure\n* Cirrhosis with evidence of portal hypertension or bridging fibrosis\n* Alcoholic hepatitis\n* Esophageal varices\n* A history of bleeding esophageal varices\n* Hepatic encephalopathy\n* Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time\n* Ascites related to portal hypertension\n* Chronic viral hepatitis with total serum bilirubin \\> 3 mg/dL\n* Symptomatic biliary disease'}, 'identificationModule': {'nctId': 'NCT00568633', 'briefTitle': 'Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission', 'orgStudyIdInfo': {'id': 'IRB-05567'}, 'secondaryIdInfos': [{'id': '97843', 'type': 'OTHER', 'domain': 'Stanford University Alternate IRB Approval Number'}, {'id': 'BMT190', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allo-HSCT + TLI + ATG', 'description': 'Participants achieving complete remission after consolidation therapy \\& who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:\n\n* Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)\n* Anti-thymocyte globulin (ATG) Days -11 to -7\n* Methylprednisolone Days -11 to -7\n* Cyclosporine (CSP) Days -4 to +2\n* 5+ of 6 HLA-matched CD34+ cells on Day 0\n* Mycophenolate mofetil (MMF), Day 0 to Day +28', 'interventionNames': ['Procedure: Allogeneic HSCT', 'Drug: Anti-thymocyte globulin (ATG)', 'Drug: Cyclosporine (CSP)', 'Drug: Mycophenolate mofetil (MMF)', 'Radiation: Total lymphoid irradiation (TLI)', 'Drug: Methylprednisolone sodium succinate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best Standard Care', 'description': 'Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:\n\n* Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation', 'interventionNames': ['Drug: Best standard care']}], 'interventions': [{'name': 'Allogeneic HSCT', 'type': 'PROCEDURE', 'otherNames': ['Hematopoietic stem cell transplantation (HSCT)', 'Peripheral blood stem cell (PBSC) transplantation'], 'description': 'Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and \\< 7 x 10e8 CD3+ cells/kg.', 'armGroupLabels': ['Allo-HSCT + TLI + ATG']}, {'name': 'Anti-thymocyte globulin (ATG)', 'type': 'DRUG', 'otherNames': ['Thymoglobulin', 'Anti-thymocyte globulin (rabbit) (ATG)'], 'description': '1.5 mg/kg for 5 days by IV', 'armGroupLabels': ['Allo-HSCT + TLI + ATG']}, {'name': 'Cyclosporine (CSP)', 'type': 'DRUG', 'otherNames': ['Ciclosporin', 'cyclosporin A', 'cyclosporin'], 'description': '6.25 mg/kg twice daily oral', 'armGroupLabels': ['Allo-HSCT + TLI + ATG']}, {'name': 'Mycophenolate mofetil (MMF)', 'type': 'DRUG', 'otherNames': ['Cellcept'], 'description': '15 mg/kg twice daily oral', 'armGroupLabels': ['Allo-HSCT + TLI + ATG']}, {'name': 'Total lymphoid irradiation (TLI)', 'type': 'RADIATION', 'description': '80 cGy/fraction radiotherapy in 10 fractions.', 'armGroupLabels': ['Allo-HSCT + TLI + ATG']}, {'name': 'Methylprednisolone sodium succinate', 'type': 'DRUG', 'otherNames': ['Solumedrol', 'Medrol', 'Depo-Medrol', 'P-Care D40', 'P-Care D80'], 'description': '1.0 mg/kg for 5 days by IV', 'armGroupLabels': ['Allo-HSCT + TLI + ATG']}, {'name': 'Best standard care', 'type': 'DRUG', 'otherNames': ['Standard of Care (physician discretion)', 'Regular medical care'], 'description': 'Intervention consist of:\n\n* Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)\n* Autologous transplantation\n* Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning\n* Umbilical cord blood transplantation\n* Haploidentical transplantation', 'armGroupLabels': ['Best Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94545', 'city': 'Hayward', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California', 'geoPoint': {'lat': 37.66882, 'lon': -122.0808}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Univeristy of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Hospital', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Robert Lowsky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Robert Lowsky', 'investigatorAffiliation': 'Stanford University'}}}}