Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test
ACROBAT
1 other identifier
observational
307
1 country
10
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
March 18, 2026
March 1, 2026
4.9 years
October 28, 2020
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the association between increased mixed chimerism (iMC) detected by AlloHeme and post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome.
Comparison of cumulative incidence of relapse post-transplant of patients with increased mixed chimerism (iMC) vs. complete chimerism (CC) vs. stable/decrease mixed chimerism (sMC/dMC) detected by AlloHeme.
Jan-2022
Secondary Outcomes (4)
To determine the association of microchimerism detected by AlloHeme on post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome
Jan-2022
To determine the association between an iMC detected by AlloHeme and disease-free survival (DFS) post-transplant in patients with acute leukemia and myelodysplastic syndrome
Jan-2022
To determine the correlation between peripheral blood chimerism detected by AlloHeme and post-transplant measurable residual disease (MRD) status in patients with acute leukemia and myelodysplastic syndrome
Jan-2022
To compare the performance of post-transplant chimerism measured by AlloHeme versus STR-PCR method for post-transplant relapse prediction in patients with acute leukemia and myelodysplastic syndrome.
Jan-2022
Eligibility Criteria
Participants aged \> 18 years old with a diagnosis of AML, ALL, and MDS who will undergo an Allo-HCT will be invited to participate and enrolled into the study at the time initial transplant evaluation or at any time before admission for transplantation.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CareDxlead
Study Sites (10)
University of California Irvine
Brisbane, California, 94005, United States
City of Hope
Duarte, California, 91010, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nishant Dwivedi, MD/PhD
CareDx
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 19, 2020
Study Start
June 30, 2021
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03