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

• Sponsor: Center for International Blood and Marrow Transplant Research (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05224661
• Collaborator: National Marrow Donor Program (Other)
• Enrollment: 1,000
• Anticipated Duration (Months): 84

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia in Remission	Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testing

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
• Anticipated Enrollment: 1000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2029
• Anticipated Study Completion Date: Jul 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Adult patients with AML in complete remission undergoing alloHCT Adult patients with AML in complete remission undergoing alloHCT	Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testing; 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).

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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).

3. 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.

4. Relapse Prediction - Time to Relapse [Through up to 3 years post-alloHCT]

   Time from testing positive by optimized monitoring to relapse.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

5. Complete remission (CR) definition per local institutional criteria

6. CR with incomplete hematologic recovery (CRi) is not an exclusion criterion

7. MRD positivity is not an exclusion criterion

8. Undergoing alloHCT

9. Has specimen from time of AML diagnosis available

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia

2. Prior alloHCT

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Center for International Blood and Marrow Transplant Research
• National Marrow Donor Program

Investigators

• Study Chair: Christopher Hourigan, DM, D.Phil., National Institutes of Health (NIH)
• Study Chair: Jeffrey Auletta, MD, National Marrow Donor Program

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Center for International Blood and Marrow Transplant Research
• ClinicalTrials.gov Identifier: NCT05224661
• Other Study ID Numbers: MEASURE
• First Posted: Feb 4, 2022
• Last Update Posted: Feb 4, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 4, 2022