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).

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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).

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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

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

1000

Study ID:

NCT05224661

Recruitment Status:

Recruiting

Sponsor:

Center for International Blood and Marrow Transplant Research

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There are 4 Locations for this study

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City of Hope
Duarte California, 91010, United States More Info
Amandeep Salhotra, MD
Contact
Amandeep Salhotra, MD
Principal Investigator
Stanford University
Stanford California, 94305, United States More Info
Lori Muffly, MD
Contact
Lori Muffly, MD
Principal Investigator
Northside Hospital
Atlanta Georgia, 30342, United States More Info
Melhem Solh, MD
Contact
Melhem Solh, MD
Principal Investigator
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
Elizabeth Krakow, MD
Contact
Elizabeth Krakow, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

1000

Study ID:

NCT05224661

Recruitment Status:

Recruiting

Sponsor:


Center for International Blood and Marrow Transplant Research

How clear is this clinincal trial information?

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