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.
Clinically diagnosed with acute leukemia.
Has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Expected to survive for more than 3 months from the date of signing the informed consent form.
Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, and has provided written informed consent.
Creatinine clearance < 60 mL/min;
Left ventricular ejection fraction (LVEF) < 55%;
Oxygen saturation (SpO₂) < 92% on room air;
Total bilirubin > 2 × the upper limit of normal (ULN);