Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for hematological malignancies. Nonetheless, poor graft function remains a life-threatening complication after allo-HSCT. Poor erythroid engraftment is associated with increased bleeding events and shorter survival. Current treatment methods such as epoetin or repeated red-cell transfusions are not effective for poor erythroid engraftment, with limited and transient responses. Retrospective studies suggested that luspatercept showed efficacy in patients with anemia post-transplantation or poor erythroid engraftment. However, there are no studies comparing luspatercept versus epoetin for the treatment of poor erythroid engraftment. Therefore, we conducted a randomized controlled study to compared the effect of luspatercept versus epoetin in treating poor erythroid engraftment for hematological malignancies.
18-65 years
Hematologic malignancies
Poor erythroid engraftment after the first allo-HSCT
Complete remission post-transplantation
Life expectancy shorter than 30 days post-transplantation
Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
Patients with any conditions not suitable for the trial (investigators' decision)
Parallel
Luspatercept
DrugLuspatercept is administered 1.0mg/kg subcutaneously every 3 weeks; If the hemoglobin level does not increase after two consecutive administrations, the dose will be adjusted to 1.3mg/kg. If the hemoglobin level returns to the normal range, Luspatercept will be given once before discontinuing the medication.
Epoetin
DrugEpoetin is administered 15000 IU subcutaneously every 3 weeks for 24 weeks
Erythroid response
Erythroid response is defined as a reduction in transfusion of ≥ 4 red blood cell units/8 weeks or a mean hemoglobin increase of ≥ 1.5 g/dL/8 weeks in the absence of transfusion
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
Relapse
Will calculate time from random assignment until relapse
Non-relapse mortality
Defined as death from any cause not subsequent to relapse
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