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

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.

Sex

All

Minimum age

18 Years

Maximum age

65 Years

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.

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