Luspatercept + Darbepoetin in Lower-Risk MDS
This study is testing a combination of two drugs, Luspatercept and Darbepoetin, for people with lower-risk myelodysplastic syndrome (MDS). MDS is a condition where your bone marrow doesn't make enough healthy blood cells. The goal is to see if this combination can help you become less dependent on blood transfusions and increase your hemoglobin levels. You might be able to join if you are 18 or older, have lower-risk MDS, and need regular red blood cell transfusions. The study plans to enroll 60 participants.
- Study design
- This is a single-arm, open-label Phase II study, meaning all 60 participants will receive the same treatment, and both you and the study staff will know which drugs are being given.
- What's involved
- You will receive Luspatercept and Darbepoetin every 21 days (three weeks). Both drugs will be given on the first day of each cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main results will be measured at 24 weeks, looking at how often you need blood transfusions and your hemoglobin levels.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Luspatercept + Darbepoetin in MDS
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Maximilian Stahl, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- Mean Rate of Red Blood Cell Transfusion Independence24 weeks
Mean rate of red blood cell transfusion independence (RBC-TI) for at least any consecutive 84 days (≥ 12 consecutive weeks) during weeks 1-24 compared to baseline in non-mutated SF3B1, lower-risk myelodysplastic syndrome patients treated with Luspatercept plus Darbepoetin Alfa
- Mean Rate of Hemoglobin Increase24 weeks
Mean rate of hemoglobin ≥ 1.5 g/dL during weeks 1-24 compared to baseline in non-mutated SF3B1, lower-risk myelodysplastic syndrome patients treated with Luspatercept plus Darbepoetin Alfa.