Acute Myeloid Leukemia Clinical Trial
Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
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).
Full 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).
Eligibility Criteria
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 specimen from time of AML diagnosis available
Exclusion Criteria:
Diagnosis of acute promyelocytic leukemia
Prior alloHCT
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There are 8 Locations for this study
Duarte California, 91010, United States More Info
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Principal Investigator
San Francisco California, 94143, United States More Info
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Stanford California, 94305, United States More Info
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Atlanta Georgia, 30342, United States More Info
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Boston Massachusetts, 02215, United States More Info
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Buffalo New York, 14263, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Seattle Washington, 98109, United States More Info
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