Clinical Trial

Luspatercept for the Treatment of Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT)

Study acronym: Allo-HSCT
Recruiting Phase 1/2
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Summary
This is a single-center, single-arm, prospective exploratory study designed to evaluate the safety and efficacy of luspatercept for the treatment of anemia following allogeneic hematopoietic stem cell transplantation in patients with acute leukemia. A total of 46 eligible subjects are planned to be enrolled. The primary efficacy endpoint is the proportion of patients achieving a hemoglobin increase of ≥1.5 g/dL at 8 weeks post-transplantation (without transfusion support) compared to baseline (the average of 3 days prior to the first dose). Secondary endpoints include assessing the impact of luspatercept on time to hematopoietic engraftment (neutrophil and platelet) and recording safety indicators such as adverse events, graft-versus-host disease, and infections. Subjects will receive subcutaneous luspatercept at 1 mg/kg on day +7 and day +28 post-transplantation.
Trial Details
NCT Number NCT07362095
Lead Sponsor Zhujiang Hospital
Conditions Acute Leukemia
Enrollment 46 participants
Start Date 2025-10-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-23