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.
Study Type
OBSERVATIONAL
Enrollment
400
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. Measuring donor cells' DNA from the recipient's blood after stem cell transplant for some types of blood cancer may provide information on the likelihood of disease relapse in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) disease populations. AlloHeme is a diagnostic test that measures donor and recipient DNA in the recipient's blood. The purpose of this study is collecting blood samples from patients who have received a stem cell transplant in order to assess the ability of the AlloHeme test to predict clinical relapse. This approach enables highly accurate and reproducible chimerism measurement with a limit of detection down to 0.02%.
CareDx, Inc.
Brisbane, California, United States
To evaluate AlloHeme test performance in predicting post-transplant relapse (by FDA criteria) or any cytogenetic/molecular evidence of disease resulting in unplanned treatment intervention in AML and MDS patients.
The performance of AlloHeme test in predicting post-transplant relapse (by FDA criteria) or any cytogenetic/molecular evidence of disease resulting in unplanned treatment intervention (modified FDA criteria) in patients with AML and MDS will be evaluated using: * Sensitivity * Specificity * PPV * NPV * AuROC
Time frame: 12 months
The performance of the AlloHeme test in predicting post-transplant relapse as defined by the FDA in patients with AML and MDS will be evaluated using: o Sensitivity o Specificity o PPV o NPV o AuROC
Time frame: 12 months
The median lead time from a positive AlloHeme test result to a relapse in post-allo-HCT AML and MDS patients.
Lead time will be defined as the duration (in days) between the date of the first AlloHeme posi-tive result and the date of documented relapse.
Time frame: 12 months
Hazard Ratio for relapse outcome.
Time frame: 12 months
The AlloHeme test performance in predicting post-transplant relapse will be compared with bone marrow MFC MRD and molecular MRD methods (NGS, qPCR, ddPCR)* in patients with AML and MDS using sensitivity, specificity, PPV, NPV, and AuROC measures.
\*If either test yields a positive result, the overall assessment will be considered positive. For molecular MRD, a "positive" result must correspond to a known pathogenic variant judged by the treating physi-cian to be clinically relevant for relapse. MFC and/or molecular MRD performance will be based on transplant center-provided bone mar-row testing results.
Time frame: 12 months
The performance of the AlloHeme and peripheral blood-based STR-PCR tests in predicting post-transplant relapse in patients with AML and MDS will be evaluated using the following measures: o Sensitivity o Specificity o PPV o NPV o AuROC
Time frame: 12 months
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