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Luspatercept + Darbepoetin in MDS
NCT07096297 · View on ClinicalTrials.gov ↗
Study Summary
This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
Conditions Studied
Interventions
- DRUG Luspatercept
- DRUG Darbeopoetin
Study Locations (3)
Connecticut
- Yale University — New Haven
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago
Texas
- Harold C. Simmons Comprehensive Cancer Center of UT Southwestern — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-12-16 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07096297
The ClinicalTrials.gov registry entry for NCT07096297 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with MDS (Myelodysplastic Syndrome) appearing as the primary indexed condition, and to 2 interventions — of which Luspatercept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07096297 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, Illinois, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07096297 about?
NCT07096297 is a clinical study titled "Luspatercept + Darbepoetin in MDS". This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
What is the current status of trial NCT07096297?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-12-16. Estimated completion is 2030-08.
What conditions does trial NCT07096297 study?
This clinical trial studies the following conditions: MDS (Myelodysplastic Syndrome). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07096297?
The interventions under investigation include: Luspatercept (DRUG), Darbeopoetin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07096297?
This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07096297 being conducted?
This trial has 3 study locations across Connecticut, Illinois, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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