Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
- Conditions
- Acute Myeloid Leukemia in Remission
- Interventions
- Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testing
- Registration Number
- NCT05224661
- 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).
- Detailed Description
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.
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 303
-
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
- CR with incomplete hematologic recovery (CRi) is not an exclusion criterion
- MRD positivity is not an exclusion criterion
-
Undergoing alloHCT
-
Has a diagnostic AML specimen available
- Diagnosis of acute promyelocytic leukemia
- Prior alloHCT
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult patients with AML in complete remission undergoing alloHCT Prospective determination of the clinical utility of measurable residual disease (MRD) testing Adult patients with AML in complete remission undergoing alloHCT
- Primary Outcome Measures
Name Time Method Overall Survival Through up to 3 years post-alloHCT Overall survival post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.
Cumulative incidence of relapse Through up to 3 years post-alloHCT Cumulative incidence of relapse post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.
- Secondary Outcome Measures
Name Time Method Relapse Prediction - Testing Approaches Through up to 3 years post-alloHCT Proportion of post-alloHCT relapses identified by different MRD testing approaches with optimal test thresholds at peri-transplant timepoints.
Relapse Prediction - Early Prediction Through up to 3 years post-alloHCT Proportion of post-alloHCT relapses identified one month or more earlier than local testing by post-alloHCT optimized monitoring.
Relapse Prediction - Pre-Transplant Testing Through up to 3 years post-alloHCT Proportion of post-alloHCT relapses predicted by pre-transplant testing (comparing blood with marrow when available).
Biology of Relapse - Change in Genetic Profile Through up to 3 years post-alloHCT for subjects with relapse sample available) - Proportion of relapses with change in genetic profile to diagnosis.
Relapse Prediction - Time to Relapse Through up to 3 years post-alloHCT Time from testing positive by optimized monitoring to relapse.
Biology of Relapse - Change in Immunophenotype Through up to 3 years post-alloHCT (for subjects with relapse sample available) - Proportion of relapses with change in immunophenotype to diagnosis.
Biology of Relapse - HLA Loss Through up to 3 years post-alloHCT (for subjects with relapse sample available) - Proportion of relapses with evidence of human leukocyte antigen (HLA) loss.
Trial Locations
- Locations (18)
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