Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation

Condition(s) studied

Investigational drug(s) / intervention(s)

Romiplostim: Participants receive romiplostim at a dose of 1 μg/kg by subcutaneous injection once weekly starting on day +3 after allo-HSCT, along with transfusion and other supportive care as clinically indicated.

Best Supportive Care (BSC): Participants will receive close monitoring and best supportive care after allogeneic hematopoietic stem cell transplantation, including transfusion support and other supportive treatments according to the clinical judgment and standard practice of treating physicians.

Study summary

This prospective, multicenter, randomized controlled Phase II study is designed to evaluate the efficacy and safety of romiplostim for platelet engraftment after haploidentical or HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation. Approximately 120 patients aged ≥18 years will be randomized equally to the romiplostim group or the best supportive care group. Romiplostim will be administered subcutaneously at 1 μg/kg once weekly, starting on day +3 after transplantation. The primary outcomes are platelet engraftment rates at days +30 after transplantation.

Eligibility

Primary outcome measure(s)

• Platelet Engraftment Rate at Day +30 After Allogeneic Hematopoietic Stem Cell Transplantation — Day +30 after allo-HSCT
  The proportion of participants who achieve platelet engraftment at day +30 after allo-HSCT will be assessed. Platelet engraftment is defined as a platelet count greater than 20×10⁹/L for 7 consecutive days without platelet transfusion support.

Trial sites (1)

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