Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
MEASURE
1 other identifier
observational
303
1 country
18
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
August 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
January 13, 2026
January 1, 2026
6.9 years
November 22, 2021
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall survival post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.
Through up to 3 years post-alloHCT
Cumulative incidence of relapse
Cumulative incidence of relapse post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.
Through up to 3 years post-alloHCT
Secondary Outcomes (7)
Relapse Prediction - Testing Approaches
Through up to 3 years post-alloHCT
Relapse Prediction - Pre-Transplant Testing
Through up to 3 years post-alloHCT
Relapse Prediction - Early Prediction
Through up to 3 years post-alloHCT
Relapse Prediction - Time to Relapse
Through up to 3 years post-alloHCT
Biology of Relapse - Change in Genetic Profile
Through up to 3 years post-alloHCT
- +2 more secondary outcomes
Study Arms (1)
Adult patients with AML in complete remission undergoing alloHCT
Adult patients with AML in complete remission undergoing alloHCT
Interventions
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
Adult patients with AML in complete remission undergoing alloHCT
You may qualify if:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged at least 18 years old at time of consent
- Diagnosed with AML, in complete remission
- Complete remission (CR) definition per local institutional criteria
- Undergoing alloHCT
- Has a diagnostic AML specimen available
You may not qualify if:
- Diagnosis of acute promyelocytic leukemia
- Prior alloHCT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
City of Hope
Duarte, California, 91010, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Stanford University
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian / Weill Cornell Medical Center
New York, New York, 10021, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Biospecimen
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)
Study Officials
- STUDY CHAIR
Christopher Hourigan, DM, D.Phil.
Virginia Polytechnic Institute and State University
- STUDY CHAIR
Jeffrey Auletta, MD
National Marrow Donor Program
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2021
First Posted
February 4, 2022
Study Start
August 26, 2022
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
January 13, 2026
Record last verified: 2026-01