RecruitingPhase 1Phase 2NCT07362095

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

An Exploratory Study on the Safety and Efficacy of Luspatercept in the Treatment of Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia

Sponsor

Zhujiang Hospital

Enrollment

46 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Leukemia

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called luspatercept can help treat anemia (low red blood cell levels) in people with acute leukemia who have received a bone marrow or stem cell transplant from a donor. **You may be eligible if...** - You have been diagnosed with acute leukemia - You have received an allogeneic (donor) stem cell or bone marrow transplant - Your hemoglobin (red blood cell level) is below 80 g/L (indicating significant anemia) - Your expected survival is more than 3 months - You are willing and able to attend follow-up visits and comply with the study plan - Women of childbearing potential must agree to use effective contraception **You may NOT be eligible if...** - Your kidney, heart, lung, or liver function is significantly impaired - You have poorly controlled high blood pressure - You have had another type of cancer in the past 5 years (other than the leukemia being treated) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLuspatercept

Study 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.