Assessment of Chimerism and Relapse Post Bone Marrow/HCT Transplant Using AlloHeme Test ACROBAT

What's the purpose of this trial?

AlloHeme is a chimerism test service that utilizes NGS technology to analyze SNP loci to quantify donor and recipient cells by measuring genomic DNA. Before transplant, patient and donor peripheral blood sample will be collected to identify informative marker for routine chimerism testing and baseline establishment for AlloHeme. Post-transplant blood or bone marrow samples are obtained and compared to the baseline sample profiles to calculate % chimerism of recipient cells in the blood and/or bone marrow samples. Cell selection from blood and bone marrow samples is applied to evaluate chimerism in specific cell subtypes that are relevant to AML and MDS diseases (CD3+ T lymphocytes, CD33+ Myeloid cells and CD15+ Granulocyte cell subtypes from blood and CD34+ hematopoietic stem cells from bone marrow).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Male or female, aged 18 years or above.
* The patient must have one of the following diseases: AML, ALL or MDS
* Eligible for allogeneic hematopoietic stem cell transplant
* Subjects must receive an Allo-HCT from an HLA matched related or unrelated donor or haploidentical donor
* Myeloablative or reduced intensity/non-myeloablative conditioning
* Any GVHD prophylaxis regimen including post-transplantation cyclophosphamide-based or conventional regimen
* 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 (Including in vivo and ex vivo T cell depletion)
* Inability to comply with medical recommendations or follow-up
* Donor is identical twin
* Pregnancy

Additional Trial Information

Observational Trial

Enrollment: 260 patients (estimated)

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Trial Locations

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California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, CA

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

New York

Herbert Irving Comprehensive Cancer Center (Columbia University) Columbia University Medical Center

New York, NY

Open and Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting
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