Trial · NCT07607327
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)
NCT07607327, Enrolling by invitation, CareDx
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD). Trials, record NCT07607327. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07607327
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)
- NCT number
- NCT07607327
- Status
- Enrolling by invitation
- Enrollment
- 400 participants, estimated
- Lead sponsor
- CareDx
- Conditions
- AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome), CMML
- Interventions
- AlloHeme
- First posted
- 2026-05-26
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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 | 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 | 12 months | |
| Secondary | The median lead time from a positive AlloHeme test result to a relapse in post-allo-HCT AML and MDS patients. | 12 months | Lead time will be defined as the duration (in days) between the date of the first AlloHeme positive result and the date of documented relapse. |
| Secondary | Hazard Ratio for relapse outcome. | 12 months | |
| Secondary | 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. | 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 physician to be clinically relevant for relapse. MFC and/or molecular MRD performance will be based on transplant center-provided bone marrow testing results. |
| Secondary | 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 | 12 months | |
| Other | 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.) | 12 months | Performance will be evaluated using: * Sensitivity * Specificity * PPV * NPV * AuROC |
| Other | 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. | 12 months | Performance will be evaluated using: * Sensitivity * Specificity * PPV * NPV * AuROC |
| Other | 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. | 12 months |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07607327
GET https://conductscience.org/api/trials/v1/NCT07607327/registered