Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-29 @ 6:46 PM
Study NCT ID:
NCT00045435
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bsandmai@fhcrc.org', 'phone': '206-667-4961', 'title': 'Dr. Brenda M. Sandmaier', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant', 'otherNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-free Survival-incidence of Survival Without Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percent', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '47', 'ciUpperLimit': '69', 'estimateComment': 'The criterion for stopping was not met.', 'groupDescription': 'The study was to be stopped after 20 patients if the upper bound of a 1-sided 95% confidence interval for relapse-free survival was \\<35%.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'By 1 year after transplant', 'description': 'Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percent', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '6', 'ciLowerLimit': '1', 'estimateComment': 'The stopping criterion was not met.', 'groupDescription': 'The study was to be stopped if the lower bound of a 1-sided 80% confidence interval for NRM was greater than 15%', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '200 days after transplant', 'description': 'Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By 1 year after transplant', 'description': 'Percent patients surviving.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By 1 year after transplant', 'description': 'Percent patients with relapsed disease post-transplant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'By 1 year after transplant', 'description': 'Percent patients who developed infections post-transplant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Acute and Chronic GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'classes': [{'title': 'Grade II-IV aGVHD', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000'}]}]}, {'title': 'cGVHD', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.', 'description': 'Percent patients with acute/chronic GVHD', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Nonmyeloablative Donor PBSC Transplant)', 'description': 'Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI \\& allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.\n\nNonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant\n\nFludarabine phosphate: Given IV\n\nTotal-body irradiation: Undergo total-body irradiation\n\nCyclosporine: Given PO\n\nMycophenolate mofetil: Given PO\n\nPeripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '72.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2002-09-06', 'resultsFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-25', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival-incidence of Survival Without Relapse', 'timeFrame': 'By 1 year after transplant', 'description': 'Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%.'}, {'measure': 'Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death', 'timeFrame': '200 days after transplant', 'description': 'Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'By 1 year after transplant', 'description': 'Percent patients surviving.'}, {'measure': 'Incidence of Relapse', 'timeFrame': 'By 1 year after transplant', 'description': 'Percent patients with relapsed disease post-transplant.'}, {'measure': 'Incidence of Rejection', 'timeFrame': 'By 1 year after transplant', 'description': 'Percent patients who developed infections post-transplant.'}, {'measure': 'Incidence of Acute and Chronic GVHD', 'timeFrame': 'aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.', 'description': 'Percent patients with acute/chronic GVHD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome', 'Adult Acute Megakaryoblastic Leukemia (M7)', 'Adult Acute Minimally Differentiated Myeloid Leukemia (M0)', 'Adult Acute Monoblastic Leukemia (M5a)', 'Adult Acute Monocytic Leukemia (M5b)', 'Adult Acute Myeloblastic Leukemia With Maturation (M2)', 'Adult Acute Myeloblastic Leukemia Without Maturation (M1)', 'Adult Acute Myeloid Leukemia in Remission', 'Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities', 'Adult Acute Myeloid Leukemia With Del(5q)', 'Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)', 'Adult Acute Myelomonocytic Leukemia (M4)', 'Adult Erythroleukemia (M6a)', 'Adult Pure Erythroid Leukemia (M6b)', 'Secondary Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '32499241', 'type': 'DERIVED', 'citation': 'Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187.'}]}, 'descriptionModule': {'briefSummary': "This phase II trial studies how well reduced intensity donor peripheral blood stem cell (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine if a one-year disease free survival of \\>= 35% can be achieved among patients \\>= 55 years old with de novo and secondary AML in first complete remission (CR1) who undergo nonmyeloablative hematopoietic stem cell transplant (HSCT) from human leukocyte antigen (HLA) identical related donors.\n\nII. To determine if a day +200 nonrelapse related mortality of \\< 15% can be achieved among patients \\>= 55 years old with de novo and secondary AML in CR1 who undergo nonmyeloablative HSCT from HLA identical related donors.\n\nOUTLINE:\n\nCONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients receive cyclosporine (CSP) orally (PO) twice daily (BID) on days -3 to 56 with taper to day 77. Patients also receive mycophenolate mofetil (MMF) PO BID on days 0-27.\n\nAfter completion of study treatment, patients are followed up on days 28, 56, and 84; months 6, 12, 18, and 24; and then yearly for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with de novo AML (French-American-British \\[FAB\\] MO-M2, M4-M7) or secondary AML who achieve CR1 after induction chemotherapy and one or two cycles of consolidation chemotherapy\n* Transplant conditioning must occur within 6 months of diagnosis\n* Patient enrollment must be approved by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator (PI) or the PI's designee\n* DONOR: Related donor who is genotypically or phenotypically identical\n* DONOR: Age \\>= 12 years\n* DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis\n* DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)\n\nExclusion Criteria:\n\n* AML FAB M3\n* AML involvement of the central nervous system (CNS) as defined by a positive cytospin of cerebral spinal fluid at the time of enrollment\n* Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology\n* Human immunodeficiency virus (HIV) seropositivity\n* Fungal infections with radiographic progression after receipt of amphotericin B or active triazole for greater than one month\n* Diffusion capacity of carbon monoxide (DLCO) corrected \\< 40%\n* Total lung capacity (TLC) \\< 40%\n* Forced expiratory volume in one second (FEV1) \\< 40% or requiring supplementary oxygen\n* The FHCRC principal investigator of the study must approve enrollment of all patients with pulmonary nodules\n* Cardiac ejection fraction \\< 40%\n* Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \\> 3mg/dL, or symptomatic biliary disease\n* Karnofsky Performance Score \\< 70\n* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment\n* Females who are pregnant or breastfeeding\n* No intensive chemotherapy can be given within three weeks (or the interval in which a cycle of standard chemotherapy would be administered in a non-transplant setting) prior to initiating the nonmyeloablative transplant conditioning\n* Patients with active non-hematologic malignancies (except non-melanoma skin cancers)\n* Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \\> 20% risk of disease recurrence\n* Patients with active bacterial or fungal infections unresponsive to medical therapy\n* DONOR: Identical twin\n* DONOR: Pregnancy\n* DONOR: HIV seropositivity\n* DONOR: Inability to achieve adequate venous access\n* DONOR: Known allergy to G-CSF\n* DONOR: Current serious systemic illness"}, 'identificationModule': {'nctId': 'NCT00045435', 'briefTitle': 'Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission', 'orgStudyIdInfo': {'id': '1654.00'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01307', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (nonmyeloablative donor PBSC transplant)', 'description': 'CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.\n\nTRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0.\n\nIMMUNOSUPPRESSION: Patients receive CSP PO BID on days -3 to 56 with taper to day 77. Patients also receive MMF PO BID on days 0-27.', 'interventionNames': ['Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation', 'Drug: fludarabine phosphate', 'Radiation: total-body irradiation', 'Drug: cyclosporine', 'Drug: mycophenolate mofetil', 'Procedure: peripheral blood stem cell transplantation']}], 'interventions': [{'name': 'nonmyeloablative allogeneic hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'description': 'Undergo nonmyeloablative allogeneic PBSC transplant', 'armGroupLabels': ['Treatment (nonmyeloablative donor PBSC transplant)']}, {'name': 'fludarabine phosphate', 'type': 'DRUG', 'otherNames': ['2-F-ara-AMP', 'Beneflur', 'Fludara'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (nonmyeloablative donor PBSC transplant)']}, {'name': 'total-body irradiation', 'type': 'RADIATION', 'otherNames': ['TBI'], 'description': 'Undergo TBI', 'armGroupLabels': ['Treatment (nonmyeloablative donor PBSC transplant)']}, {'name': 'cyclosporine', 'type': 'DRUG', 'otherNames': ['ciclosporin', 'cyclosporin', 'cyclosporin A', 'CYSP', 'Sandimmune'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (nonmyeloablative donor PBSC transplant)']}, {'name': 'mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['Cellcept', 'MMF'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (nonmyeloablative donor PBSC transplant)']}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['PBPC transplantation', 'PBSC transplantation', 'peripheral blood progenitor cell transplantation', 'transplantation, peripheral blood stem cell'], 'description': 'Undergo nonmyeloablative allogeneic PBSC transplant', 'armGroupLabels': ['Treatment (nonmyeloablative donor PBSC transplant)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Brenda Sandmaier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brenda Sandmaier', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}