Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)

Part of paid clinical trials in Brisbane, California.

Sponsor
CareDx
Study ID
NCT07607327
Status
Not Yet Recruiting

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Conditions

  • AML (Acute Myelogenous Leukemia)
  • CMML
  • MDS (Myelodysplastic Syndrome)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AlloHeme — DIAGNOSTIC_TEST
    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%.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
400 participants (estimated)

Primary Outcome Measure

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. [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CareDx, Inc.BrisbaneCalifornia94080
Nishant Dwivedi, MD, PhD
[email protected]
508-981-6087
Nishant Dwivedi, MD, PhD
[email protected]

Find similar trials in Brisbane, CA

By research site
CareDx, Inc.· Brisbane, CA

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