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RECRUITING
NCT07362095
PHASE1/PHASE2

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

Sponsor: Zhujiang Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2025-10-01

Completion Date

2028-05-31

Last Updated

2026-01-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

Luspatercept

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 If the ±3-day window is exceeded, the subject will be withdrawn from the study treatment.

Locations (1)

Zhujiang Hospital

Guangzhou, Guangdong, China