Clinical Trial 21561

• Overview

  Study Title:

  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.

• Inclusion Criteria

  • 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 subject must be enrolled prior to allo-HCT

• Exclusion Criteria

  • 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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