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).
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).
Study Type
OBSERVATIONAL
Enrollment
303
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).
City of Hope
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
Overall Survival
Overall survival post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.
Time frame: 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.
Time frame: Through up to 3 years post-alloHCT
Relapse Prediction - Testing Approaches
Proportion of post-alloHCT relapses identified by different MRD testing approaches with optimal test thresholds at peri-transplant timepoints.
Time frame: Through up to 3 years post-alloHCT
Relapse Prediction - Pre-Transplant Testing
Proportion of post-alloHCT relapses predicted by pre-transplant testing (comparing blood with marrow when available).
Time frame: Through up to 3 years post-alloHCT
Relapse Prediction - Early Prediction
Proportion of post-alloHCT relapses identified one month or more earlier than local testing by post-alloHCT optimized monitoring.
Time frame: Through up to 3 years post-alloHCT
Relapse Prediction - Time to Relapse
Time from testing positive by optimized monitoring to relapse.
Time frame: Through up to 3 years post-alloHCT
Biology of Relapse - Change in Genetic Profile
for subjects with relapse sample available) - Proportion of relapses with change in genetic profile to diagnosis.
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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
...and 8 more locations
Time frame: Through up to 3 years post-alloHCT
Biology of Relapse - Change in Immunophenotype
(for subjects with relapse sample available) - Proportion of relapses with change in immunophenotype to diagnosis.
Time frame: Through up to 3 years post-alloHCT
Biology of Relapse - HLA Loss
(for subjects with relapse sample available) - Proportion of relapses with evidence of human leukocyte antigen (HLA) loss.
Time frame: Through up to 3 years post-alloHCT