NCT05224661

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 303 (actual)
• Sponsor: Center for International Blood and Marrow Transplant Research · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia in Remission

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-08-26
• Primary completion: 2029-07-01
• Completion: 2029-07-01
• First posted: 2022-02-04
• Last updated: 2026-01-13

Locations

18 sites across 1 country: United States