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NCT Number: NCT07607327

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

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.

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Key information

Conditions

AML (Acute Myelogenous Leukemia) Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases CMML Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute MDS (Myelodysplastic Syndrome) Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or above.
  • 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).
  • Participant must receive an allo-HCT from an HLA-matched related or unrelated donor, an HLA-mismatched donor, or a haploidentical donor.
  • Participant can be enrolled before, at, or up to 1-month post-allo-HCT as long as the participant is in complete remission (CR) at Day 30 and that a recipient pre-transplant or donor sample is available for baseline genotyping (reference). If the reference sample is unavailable or fails testing, the buccal swab collected at Day 30 may be used as the reference sample.
  • Myeloablative or reduced intensity/non-myeloablative conditioning except T-cell depleting therapies (Ex-vivo T cell depletion, CD34 selected graft, use of anti-thymocyte globulin or alemtuzumab).
  • Any graft versus host disease (GVHD) prophylaxis regimen.
  • Willing and able to provide written informed consent.
  • Willing and able to comply with study visits and procedures, including scheduled sample collections and clinical assessments

Exclusion criteria

  • History of prior allo-HCT or any prior solid organ transplant.
  • Syngeneic donor (identical twin).
  • T cell depleted transplant (Ex-vivo T cell depletion, CD34 selected graft, use of antithymocyte globulin or alemtuzumab in the conditioning regimen)
  • Cord blood graft.
  • Pregnancy
  • Any condition that, in the investigator's opinion, would interfere with the participant's ability to comply with study procedures or jeopardize their safety.
  • Concurrent participation in an interventional or maintenance clinical trial for post allo-HCT relapse prevention; co-enrollment with other trials, such as those intended for GVHD / infection prevention or improving supportive care, is allowed.

Treatment and study plan

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%.

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. 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

  2. The median lead time from a positive AlloHeme test result to a relapse in post-allo-HCT AML and MDS patients.

    Time frame: 12 months

    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.

  3. Hazard Ratio for relapse outcome.

    Time frame: 12 months

  4. 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.

    Time frame: 12 months

    *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.

  5. 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

Other outcomes

  1. The performance of the AlloHeme test in predicting post-transplant relapse will be described in subgroups of interest (AML vs MDS/CMML, conditioning regimen, risk assessment, etc.)

    Time frame: 12 months

    Performance will be evaluated using:

    • Sensitivity
    • Specificity
    • PPV
    • NPV
    • AuROC

  2. The performance of the AlloHeme test in predicting or detecting positive MRD as measured on bone marrow MFC MRD and/or molecular MRD testing modalities.

    Time frame: 12 months

    Performance will be evaluated using:

    • Sensitivity
    • Specificity
    • PPV
    • NPV
    • AuROC

  3. Relapse-free survival will be measured as the time interval from allo-HCT to the documented date of relapse or death from any cause and will be compared between the AlloHeme Positive and Negative groups.

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Nishant Dwivedi, MD, PhD

CONTACT

[email protected]

508-981-6087

Sponsors and collaborators

Lead sponsor

CareDx

Industry

Registry information

Official study title

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

Acronym: FORWARD

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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