Phase II Study of Luspatercept and Darbepoetin Alfa for Lower-risk Non-mutated SF3B1 Myelodysplastic Syndrome with Red Blood Cell Transfusion Dependence

What this Trial Is About

Researchers are evaluating the combination of luspatercept and darbepoetin alfa in adults with non-mutated SF3B1 lower-risk myelodysplastic syndrome MDS who depend on red blood cell RBC transfusions and have low erythropoietin levels. This Phase II open-label trial focuses on participants with lower-risk MDS characterized by specific criteria, aiming to assess transfusion independence and hemoglobin increase over 24 weeks. Participants receive both luspatercept and darbepoetin alfa every 21 days, with doses administered on day one of each cycle. Treatment doses may be adjusted based on individual responses, starting from luspatercept at 1.0 mgkg and darbepoetin alfa at 300 micrograms. Both drugs are given by subcutaneous injection at clinical sites following institutional guidelines. During the study, participants undergo regular assessments including blood tests, hemoglobin monitoring, and quality of life questionnaires at baseline and throughout treatment cycles. Researchers measure outcomes such as the rate and duration of RBC transfusion independence, hematological improvement, and changes in health-related quality of life using validated tools. The study includes follow-up visits up to approximately 2.5 years to monitor safety and ongoing effects.

Luspatercept + Darbepoetin in MDS