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.
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
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);
Parallel
Luspatercept
DrugOn 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
Other interventionThe patient will receive the best supportive treatment including blood transfusion.
Cumulative incidence of poor erythroid engraftment
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.
Red blood cell units
The number of red blood cell units administered
Overall survival
Will calculate time from random assignment until death from any cause.
Disease-free survival
Will calculate time from random assignment until relapse or death from any cause
Cumulative rate of poor graft engraftment
The definition of PGF is as follows: More than 28 days after transplantation, there is at least a continuous period of 3 days of two-line or three-line blood cell reduction (absolute neutrophil count \< 0.5 × 109/L, platelet (PLT) \< 20 × 109/L, hemoglobin (HGB) \< 70 g/L), and blood transfusion support treatment is required; bone marrow examination indicates a low degree of bone marrow hyperplasia; complete donor engraftment; no active severe GVHD or hematological recurrence.
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