Assessment of Chimerism and Relapse Post-Bone Marrow / Hematopoietic Cell Transplant (HCT) using ALLOHEME Test (ACROBAT)
Summary
This observational cohort study will evaluate the correlation of chimerism status detected by a highly sensitive AlloHeme method with post-transplant relapse in patients with acute leukemias and MDS receiving allo-HCT
Objective
Primary Objective
To determine the association between an iMC detected by AlloHeme and post-transplant relapse in patients with AML, MDS, or ALL.
Secondary Objectives
To determine the association between longitudinal measurement of mixed- chimerism (MC) detected by AlloHeme and post-transplant relapse in patients with AML, MDS, or ALL.
To determine the association of microchimerism detected by AlloHeme on post-transplant relapse in patients with AML, MDS, or ALL.
To determine the association between an iMC detected by AlloHeme and disease-free survival post-transplant in patients with AML, MDS, or ALL.
To determine the correlation of donor chimerism quantitatively detected by AlloHeme and post-transplant measurable residual disease (MRD) in patients with AML, MDS, or ALL.
To compare the performance of post-transplant chimerism measured by Alloheme versus STR-PCR method for post-transplant relapse prediction in patients with AML, MDS, or ALL.
Participant is willing and able to give informed consent for participation in the study.
Male or female, aged 18 years or above
Must have one of the following diseases: AML, MDS, or ALL
Eligible for allogeneic hematopoietic stem cell transplant
Subjects must receive an allo-HCT from an HLA matched related or unrelated donor or haploidentical donor (excluding identical twin donor as defined below under Section 5.3)
Myeloablative or reduced intensity/non-myeloablative conditioning
The participant may not enter the study if ANY of the following apply:
Has history of prior allo-HCT
T cell depleted transplant (Ex-vivo T cell depletion, CD34 selected graft, use of anti-thymocyte globulin or alemtuzumab in the conditioning regimen)
Cord blood graft
Inability to comply with medical recommendations or follow-up
Donor is identical twin
Pregnancy
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