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

Starting soon · Phase 2/Phase 3

Conditions studied: Luspatercept, Poor Erythroid Engraftment, Hematological Malignancies, Myelofibrosis (MF)

In brief

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.

Key facts

Study ID

NCT07539779

Run by

Nanfang Hospital, Southern Medical University

People needed

196

Starts

2026-05-01

Expected to finish

2030-12-31

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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