Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT01588951
Status:
TERMINATED
Last Update Posted:
2018-08-14
First Post:
2012-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014184', 'term': 'Transplantation, Homologous'}, {'id': 'D016026', 'term': 'Bone Marrow Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017690', 'term': 'Cell Transplantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mshowel1@jhmi.edu', 'phone': '410-614-0675', 'title': 'Margaret Showel, MD', 'organization': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Collected monthly for up to 3.5 years.', 'description': 'Only unexpected adverse events, grades III-IV acute GVHD, and chronic GVHD were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'No Leukemia Stem Cells - Consolidation', 'description': 'Without LSC, standard cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Leukemia Stem Cells - Consolidation', 'description': 'LSC present, randomized to cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Leukemia Stem Cells - Transplant', 'description': 'LSC present, randomized to allogeneic transplant\n\nAllogeneic transplant: Allogeneic stem cell transplant per institutional standards.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relapse Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No Leukemia Stem Cells - Consolidation', 'description': 'Without LSC, standard cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.'}, {'id': 'OG001', 'title': 'Leukemia Stem Cells - Consolidation', 'description': 'LSC present, randomized to cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.'}, {'id': 'OG002', 'title': 'Leukemia Stem Cells - Transplant', 'description': 'LSC present, randomized to allogeneic transplant\n\nAllogeneic transplant: Allogeneic stem cell transplant per institutional standards.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Percentage of participants alive and without relapsed disease at two years.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Leukemia Stem Cells - Consolidation', 'description': 'Without LSC, standard cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.'}, {'id': 'FG001', 'title': 'Leukemia Stem Cells - Consolidation', 'description': 'LSC present, randomized to cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.'}, {'id': 'FG002', 'title': 'Leukemia Stem Cells - Transplant', 'description': 'LSC present, randomized to allogeneic transplant\n\nAllogeneic transplant: Allogeneic stem cell transplant per institutional standards.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Ineligible in retrospect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'No Leukemia Stem Cells - Consolidation', 'description': 'Without LSC, standard cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.'}, {'id': 'BG001', 'title': 'Leukemia Stem Cells - Consolidation', 'description': 'LSC present, randomized to cytarabine consolidation\n\nCytarabine consolidation: Cytarabine-based consolidation per institutional standards.'}, {'id': 'BG002', 'title': 'Leukemia Stem Cells - Transplant', 'description': 'LSC present, randomized to allogeneic transplant\n\nAllogeneic transplant: Allogeneic stem cell transplant per institutional standards.'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-18', 'size': 935420, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-20T09:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2012-04-27', 'resultsFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2012-04-30', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-01', 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse Free Survival', 'timeFrame': '2 years', 'description': 'Percentage of participants alive and without relapsed disease at two years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than or equal to 18 years\n2. Able to give informed consent\n3. New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2\n\nExclusion criteria:\n\n1. Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy\n2. Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up\n3. Pregnancy: Women of childbearing potential who are β- HCG+'}, 'identificationModule': {'nctId': 'NCT01588951', 'briefTitle': 'Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior', 'orgStudyIdInfo': {'id': 'J1227'}, 'secondaryIdInfos': [{'id': 'NA_00071844', 'type': 'OTHER', 'domain': 'JHMIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No Leukemia Stem Cells - Consolidation', 'description': 'Without LSC, standard cytarabine consolidation', 'interventionNames': ['Drug: Cytarabine consolidation']}, {'type': 'EXPERIMENTAL', 'label': 'Leukemia Stem Cells - Consolidation', 'description': 'LSC present, randomized to cytarabine consolidation', 'interventionNames': ['Drug: Cytarabine consolidation']}, {'type': 'EXPERIMENTAL', 'label': 'Leukemia Stem Cells - Transplant', 'description': 'LSC present, randomized to allogeneic transplant', 'interventionNames': ['Drug: Allogeneic transplant']}], 'interventions': [{'name': 'Cytarabine consolidation', 'type': 'DRUG', 'otherNames': ['HiDAC'], 'description': 'Cytarabine-based consolidation per institutional standards.', 'armGroupLabels': ['Leukemia Stem Cells - Consolidation', 'No Leukemia Stem Cells - Consolidation']}, {'name': 'Allogeneic transplant', 'type': 'DRUG', 'otherNames': ['Bone marrow transplant', 'Stem cell transplant', 'Hematopoietic stem cell transplant', 'BMT', 'HSCT'], 'description': 'Allogeneic stem cell transplant per institutional standards.', 'armGroupLabels': ['Leukemia Stem Cells - Transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Margaret Showel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'JHU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}