Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test

Running, not enrolling

Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

In brief

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).

Key facts

Study ID

NCT04635384

Run by

CareDx

People needed

307

Starts

2021-06-30

Expected to finish

2026-08-31

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Irvine — Brisbane, California, United States
• City of Hope — Duarte, California, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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