Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT05224661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-01', 'size': 377423, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-17T15:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Bone Marrow (if collected for clinical purposes only), archived specimens from time of AML diagnosis (diagnosis specimens include: bone marrow aspirate cells, extracted DNA, marrow aspirate pellet, marrow aspirate slides, blood)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': 'Overall survival post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': 'Cumulative incidence of relapse post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.'}], 'secondaryOutcomes': [{'measure': 'Relapse Prediction - Testing Approaches', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': 'Proportion of post-alloHCT relapses identified by different MRD testing approaches with optimal test thresholds at peri-transplant timepoints.'}, {'measure': 'Relapse Prediction - Pre-Transplant Testing', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': 'Proportion of post-alloHCT relapses predicted by pre-transplant testing (comparing blood with marrow when available).'}, {'measure': 'Relapse Prediction - Early Prediction', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': 'Proportion of post-alloHCT relapses identified one month or more earlier than local testing by post-alloHCT optimized monitoring.'}, {'measure': 'Relapse Prediction - Time to Relapse', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': 'Time from testing positive by optimized monitoring to relapse.'}, {'measure': 'Biology of Relapse - Change in Genetic Profile', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': 'for subjects with relapse sample available) - Proportion of relapses with change in genetic profile to diagnosis.'}, {'measure': 'Biology of Relapse - Change in Immunophenotype', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': '(for subjects with relapse sample available) - Proportion of relapses with change in immunophenotype to diagnosis.'}, {'measure': 'Biology of Relapse - HLA Loss', 'timeFrame': 'Through up to 3 years post-alloHCT', 'description': '(for subjects with relapse sample available) - Proportion of relapses with evidence of human leukocyte antigen (HLA) loss.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia in Remission']}, 'descriptionModule': {'briefSummary': 'Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT).', 'detailedDescription': 'This is a multi-center non-randomized prospective study designed to establish a national framework for introducing measurable residual disease testing into the clinical care of AML patients undergoing allogeneic transplantation.\n\nEnrollment is expected to occur over a 4-year period, with an additional 3 years of follow-up. Subject participation this study will be approximately 3 years. Up to 1,000 subjects will be enrolled.\n\nSubjects will be asked to provide blood samples at months 1-6, 9, 12, 15, and 18 post-transplant, and archived specimens from time of AML diagnosis and any bone marrow samples collected for clinical purposes will be requested for research testing. Additional blood and marrow samples will be requested at relapse (if applicable).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with AML in complete remission undergoing alloHCT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Aged at least 18 years old at time of consent\n4. Diagnosed with AML, in complete remission\n\n 1. Complete remission (CR) definition per local institutional criteria\n 2. CR with incomplete hematologic recovery (CRi) is not an exclusion criterion\n 3. MRD positivity is not an exclusion criterion\n5. Undergoing alloHCT\n6. Has a diagnostic AML specimen available\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia\n2. Prior alloHCT'}, 'identificationModule': {'nctId': 'NCT05224661', 'acronym': 'MEASURE', 'briefTitle': 'Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events', 'organization': {'class': 'NETWORK', 'fullName': 'Center for International Blood and Marrow Transplant Research'}, 'officialTitle': 'Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events', 'orgStudyIdInfo': {'id': 'MEASURE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients with AML in complete remission undergoing alloHCT', 'description': 'Adult patients with AML in complete remission undergoing alloHCT', 'interventionNames': ['Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testing']}], 'interventions': [{'name': 'Prospective determination of the clinical utility of measurable residual disease (MRD) testing', 'type': 'OTHER', 'description': 'Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT).', 'armGroupLabels': ['Adult patients with AML in complete remission undergoing alloHCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian / Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Christopher Hourigan, DM, D.Phil.', 'role': 'STUDY_CHAIR', 'affiliation': 'Virginia Polytechnic Institute and State University'}, {'name': 'Jeffrey Auletta, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Marrow Donor Program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for International Blood and Marrow Transplant Research', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Marrow Donor Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}