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

NCT07539779 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Phase 2/3

Started

2026-05-01

Last updated

2026-04-20

Condition(s) studied

LuspaterceptPoor Erythroid EngraftmentHematological MalignanciesMyelofibrosis (MF)

Investigational drug(s) / intervention(s)

LuspaterceptControl

Luspatercept: On the 7th day after allo-HSCT, the first dose of Luspatercept 1.0mg/kg was administered subcutaneously. If the peripheral blood HGB was \< 70g/L on the 21st day after allo-HSCT, the second dose of Luspatercept 1.0mg/kg was given subcutaneously; if the peripheral blood HGB was ≥ 70g/L on the 21st day after allo-HSCT, no second dose of Luspatercept subcutaneous injection was given.

Control: The patient will receive the best supportive treatment including blood transfusion.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * 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 * In a CR state before transplantation. Exclusion Criteria: * 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); * Has severe liver dysfunction, with liver function indicators (aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL)) more than twice the upper limit of normal; * Has severe renal dysfunction, with creatinine (Cr) more than twice the upper limit of normal or 24-hour creatinine clearance rate (Ccr) lower than 30 ml/min; * Has severe active bleeding; * Patients judged by the investigator to be unsuitable for participating in this trial.

Primary outcome measure(s)

Cumulative incidence of poor erythroid engraftment — 28 days
Poor erythroid engraftment after allo-HSCT is defined as HGB \< 70g/L at 28 days post-transplantation and the inability to discontinue red blood cell transfusion in the case of complete donor engraftment.

Trial sites (1)

Facility	City	Region	Status
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07539779 on ClinicalTrials.gov ↗ ← All trials in China