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

Status
Active
Cancer Type
Leukemia
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCT ID
NCT05224661
Protocol IDs
MEASURE (primary)
NCI-2022-03314
Study Sponsor
Center for International Blood and Marrow Transplant Research

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).

Objectives

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).

Eligibility

  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

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.