Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD): A Multicenter, Prospective Observational Cohort Study in US Transplant Centers
CareDx
Summary
AlloHeme is a blood-based monitoring test developed by the CareDx laboratory that utilizes NGS technology coupled with a proprietary algorithm to predict the likelihood of a relapse in post-allo-HCT AML/MDS patients. The technology analyzes 405 single nucleotide polymorphisms (SNPs) selected from across all somatic chromosomes between the donor and the recipient. Pre-transplant DNA is obtained from donor and/or recipient to identify specific donor and recipient SNPs (baseline samples). Post-transplant blood samples are obtained and compared to the baseline sample profiles to precisely calculate the percentage chimerism of recipient cells in the blood samples using a proprietary quantitative method and unique dual indexing that optimizes recipient DNA at trace levels. This approach enables highly accurate and reproducible chimerism measurement with a limit of detection down to 0.02%. The AlloHeme test leverages a proprietary algorithm that integrates this multi-analyte longitudinal chimerism data with post-transplant time points to predict the likelihood of a clinical relapse for AML/MDS patients following an allo-HCT.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults aged 18 years or above. 2. The participant must have one of the following diseases: AML or MDS (including CMML) and be eligible for allogeneic hematopoietic stem cell transplant. For participants with active disease (\> 5% blasts) before HCT, the treating physician must have the intent to perform a bone marrow examination at day 30 post-HCT as SOC patient management to confirm complete remission (\<5% blasts). 3. Participant must receive an allo-HCT from an HLA-matched related or unrelated donor, an HLA-mismatched donor, or a haploidentical donor. 4. Participant…