Study of Avatrombopag to Treat Low Platelet Counts After Haploidentical Stem Cell Transplantation A Randomized, Double-Blind, Placebo-Controlled Multi-Center Trial

What this Trial Is About

Researchers are evaluating the effectiveness of avatrombopag in patients who develop thrombocytopenia after haploidentical hematopoietic stem cell transplantation haplo-HSCT. Thrombocytopenia, including primary isolated thrombocytopenia and secondary failure of platelet recovery, is a serious complication that can lead to bleeding, infection, and affect overall survival, disease-free survival, and non-relapse mortality. This trial is a prospective, multi-center, double-blinded, randomized placebo-controlled study designed to provide evidence for avatrombopags use in this setting. Participants are randomly assigned to receive either avatrombopag or a placebo starting on day 7 after haplo-HSCT. The starting dose is 20 mg daily taken orally, with adjustments based on platelet levels or transfusion dependence up to day 60 after transplantation. Dosage may be increased to 40 mg daily if platelet counts remain low by day 30, or decreased or stopped if platelet counts improve. Routine treatments and platelet transfusions are permitted as needed during the study. Throughout the study, participants will have their platelet levels monitored regularly, along with assessments of neutrophil recovery, graft-versus-host disease, infections, and survival outcomes up to one year post-transplant. The primary measurement is the proportion of patients achieving a platelet count of at least 50109L by day 60 without requiring platelet transfusion for seven or more consecutive days. Secondary outcomes include platelet counts at other time points, transfusion needs, and survival rates. Safety and treatment response will be closely followed during the trial period.

Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT