Luspatercept vs Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanfang Hospital, Southern Medical University

About this trial

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

Qualifiers

18-65 years

Hematologic malignancies

Poor erythroid engraftment after the first allo-HSCT

Complete remission post-transplantation

Disqualifiers

Life expectancy shorter than 30 days post-transplantation

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)

Patients with any conditions not suitable for the trial (investigators' decision)

Trial design

Treatments tested in this trial

  • Luspatercept
  • Epoetin

Treatment groups

90 Participants
are divided into 2 treatment groups