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NOT YET RECRUITING
NCT07636486
PHASE2/PHASE3

Luspatercept vs Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for hematological malignancies. Nonetheless, poor graft function remains a life-threatening complication after allo-HSCT. Poor erythroid engraftment is associated with increased bleeding events and shorter survival. Current treatment methods such as epoetin or repeated red-cell transfusions are not effective for poor erythroid engraftment, with limited and transient responses. Retrospective studies suggested that luspatercept showed efficacy in patients with anemia post-transplantation or poor erythroid engraftment. However, there are no studies comparing luspatercept versus epoetin for the treatment of poor erythroid engraftment. Therefore, we conducted a randomized controlled study to compared the effect of luspatercept versus epoetin in treating poor erythroid engraftment for hematological malignancies.

Official title: Luspatercept Versus Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-06-15

Completion Date

2030-12-31

Last Updated

2026-06-09

Healthy Volunteers

No

Interventions

DRUG

Luspatercept

Luspatercept is administered 1.0mg/kg subcutaneously every 3 weeks; If the hemoglobin level does not increase after two consecutive administrations, the dose will be adjusted to 1.3mg/kg. If the hemoglobin level returns to the normal range, Luspatercept will be given once before discontinuing the medication.

DRUG

Epoetin

Epoetin is administered 15000 IU subcutaneously every 3 weeks for 24 weeks

Locations (1)

Department of Hematology, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China