Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
NCT ID: NCT05224661
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
303 participants
OBSERVATIONAL
2022-08-26
2029-07-01
Brief Summary
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Detailed Description
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Enrollment 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.
Subjects 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).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Adult patients with AML in complete remission undergoing alloHCT
Adult patients with AML in complete remission undergoing alloHCT
Prospective determination of the clinical utility of measurable residual disease (MRD) testing
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).
Interventions
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Prospective determination of the clinical utility of measurable residual disease (MRD) testing
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).
Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Aged at least 18 years old at time of consent
4. Diagnosed with AML, in complete remission
1. Complete remission (CR) definition per local institutional criteria
2. CR with incomplete hematologic recovery (CRi) is not an exclusion criterion
3. MRD positivity is not an exclusion criterion
5. Undergoing alloHCT
6. Has a diagnostic AML specimen available
Exclusion Criteria
2. Prior alloHCT
18 Years
ALL
No
Sponsors
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National Marrow Donor Program
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Christopher Hourigan, DM, D.Phil.
Role: STUDY_CHAIR
Virginia Polytechnic Institute and State University
Jeffrey Auletta, MD
Role: STUDY_CHAIR
National Marrow Donor Program
Locations
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City of Hope
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
University of Chicago Medicine
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Presbyterian / Weill Cornell Medical Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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MEASURE
Identifier Type: -
Identifier Source: org_study_id
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