This study is in progress, not accepting new patients

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

a study on Acute Myeloid Leukemia Leukemia Bone Marrow Transplant Stem Cell Transplant Transplants

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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).

Details

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).

Keywords

Acute Myeloid Leukemia in Remission, Prospective determination of the clinical utility of measurable residual disease (MRD) testing

Eligibility

You can join if…

Open to people ages 18 years and up

  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
    1. Complete remission (CR) definition per local institutional criteria
    2. CR with incomplete hematologic recovery (CRi) is not an exclusion criterion
    3. MRD positivity is not an exclusion criterion
  5. Undergoing alloHCT
  6. Has a diagnostic AML specimen available

You CAN'T join if...

  1. Diagnosis of acute promyelocytic leukemia
  2. Prior alloHCT

Locations

  • UCSF
    San Francisco California 94143 United States
  • Stanford University
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Center for International Blood and Marrow Transplant Research
ID
NCT05224661
Study Type
Observational
Participants
About 303 people participating
Last Updated