Luspatercept vs Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies

Conditions: Luspatercept, Epoetin, Poor Erythroid Engraftment, Hematological Malignancies

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: PHASE2, PHASE3

Enrollment: 90

Sponsor: Nanfang Hospital, Southern Medical University

Location: Department of Hematology, Nanfang Hospital, Southern Medical University Guangzhou Guangdong

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.

Eligibility Criteria

Inclusion Criteria: * 18-65 years * Hematologic malignancies * Poor erythroid engraftment after the first allo-HSCT * Complete remission post-transplantation * Eastern Cooperative Oncology Group performance status of 0-2 * Epoetin-naive * Endogenous serum erythropoietin concentration \

Source: ClinicalTrials.gov (NCT07636486). StuddyBuddy aggregates publicly available trial information.