Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 303
- Locations
- 18
- Primary Endpoint
- Overall Survival
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Diagnosis of acute promyelocytic leukemia
- •Prior alloHCT
Arms & Interventions
Adult patients with AML in complete remission undergoing alloHCT
Adult patients with AML in complete remission undergoing alloHCT
Intervention: Prospective determination of the clinical utility of measurable residual disease (MRD) testing (Other)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 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
Time Frame: 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 Outcomes
- Relapse Prediction - Testing Approaches(Through up to 3 years post-alloHCT)
- Relapse Prediction - Early Prediction(Through up to 3 years post-alloHCT)
- Relapse Prediction - Pre-Transplant Testing(Through up to 3 years post-alloHCT)
- Biology of Relapse - Change in Genetic Profile(Through up to 3 years post-alloHCT)
- Relapse Prediction - Time to Relapse(Through up to 3 years post-alloHCT)
- Biology of Relapse - Change in Immunophenotype(Through up to 3 years post-alloHCT)
- Biology of Relapse - HLA Loss(Through up to 3 years post-alloHCT)