Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events

Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events

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).

Inclusion Criteria:

1. Provision of signed and dated informed consent form

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:

1. Diagnosis of acute promyelocytic leukemia
2. Prior alloHCT