Luspatercept in Preventing Poor Erythroid Engraftment for Hematological Malignancies With Moderate to Severe Myelofibrosis

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 important treatment for hematological malignancies. Poor erythroid engraftment after transplantation is a serious complication, especially in patients with moderate to severe myelofibrosis (MF). Currently, there is a lack of effective prevention strategies for poor erythroid engraftment after transplantation. Luspatercept, a novel TGF-β superfamily signaling pathway modulator, has shown potential in small-sample studies for the treatment and prevention of post-transplant anemia. Given the high proportion and poor prognosis of poor engraftment function in hematological malignancies with moderate to severe myelofibrosis after transplantation, we plan to conduct a prospective, multicenter, randomized controlled study to explore the efficacy and safety of luspatercept in preventing poor erythroid engraftment after allo-HSCT in hematological malignancies with moderate to severe myelofibrosis.

Eligibility criteria

Qualifiers

Age 18-65 years old, gender not restricted;

ECOG score 0-2 points;

Hematological malignancies with moderate to severe myelofibrosis

Willing to undergo the first allo-HSCT with a suitable donor

Disqualifiers

Has previously undergone allo-HSCT;

ECOG score is 3-5;

Expected lifespan after transplantation is less than 30 days;

Has severe cardiac dysfunction, severe arrhythmia or severe pulmonary dysfunction (obstructive and/or restrictive ventilation disorder);

Trial design

Treatments tested in this trial

  • Luspatercept
  • Control

Treatment groups

196 Participants
are divided into 2 treatment groups