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);
Single group
Luspatercept
DrugStudy Treatment and Dosing Schedule According to the protocol, subcutaneous injections will be administered at a dose of 1 mg/kg on day +7 and day +28 post-transplantation. Inject into the upper arm, thigh, or abdomen. Doses requiring a larger volume (\>1.2 mL) should be divided into similar volumes in separate syringes and injected at different sites. Use a new syringe and needle for each separate injection. Missed Dose: A dosing window of ±3 days is allowed, i.e., within day +7 ±3 days and day +28 ±3 days post-transplantation. If delayed, administer as soon as possible and continue with the regular dosing schedule (maintaining at least a 3-week interval between doses). If the ±3-day window is exceeded, the subject will be withdrawn from the study treatment.
Proportion of patients with reduced transfusion requirement
Proportion of patients achieving an increase in Hb of ≥1.5 g/dL at 8 weeks post-Allo-HSCT (without transfusion support) compared to the pre-first-dose baseline (average Hb level from the three days prior to the first dose).
Time to Granulocyte Engraftment
Time interval from the day of stem cell infusion to the first day of three consecutive days with an absolute neutrophil count (ANC) greater than 0.5 G/L.
Time to Platelet Engraftment
Time interval from the day of stem cell infusion to the first day of three consecutive days with an absolute platelet count ≥40 × 10⁹/L.
Incidence of drug-related adverse reactions
Record the occurrence of all adverse events, including the event type, severity, time of onset, relationship to the drug, and management actions taken. Analyze the incidence of adverse reactions (possibly) related to the drug, and the incidence of Grade ≥3 adverse reactions.
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