NCT04635384Completed
Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test
Assessment of Chimerism and Relapse Post Bone Marrow/HCT Transplant Using AlloHeme Test (ACROBAT)
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 307 (actual)
- First submitted
- 28 Oct 2020
- Start date
- 22 Jul 2021
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- CareDx
- NCT number
- NCT04635384
What you commit to
- Study type: Observational
- Participants enrolled: 307
- From 22 Jul 2021 to the primary completion date, 30 Sept 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has history of prior Allo-HCT
- T cell depleted transplant (Including in vivo and ex vivo T cell depletion)
Other
- The participant may not enter the study if ANY of the following apply:
- Inability to comply with medical recommendations or follow-up
- Donor is identical twin
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Georgia Cancer Center at Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Brisbane | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| H Lee Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.