Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the association between increased mixed chimerism (iMC) detected by AlloHeme and post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome.
- timeFrame
- Jan-2022
- description
- 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.
Secondary outcomes (4)
- measure
- To determine the association of microchimerism detected by AlloHeme on post-transplant relapse in patients with acute leukemia and myelodysplastic syndrome
- timeFrame
- Jan-2022
- description
- Comparison of cumulative incidence of relapse post-transplant of patients with microchimerism vs. CC detected by AlloHeme
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available