Retrospective Clinical Study on the Efficacy and Safety of Romiplostim for Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Time to Platelet Recovery to ≥50×10⁹/L
研究概览
简要总结
This is a retrospective observational study evaluating the efficacy and safety of romiplostim for promoting platelet engraftment in patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Medical records were reviewed to collect data on platelet recovery time, transfusion requirements, and adverse events. The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.No interventions were assigned as part of this study.
详细描述
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important curative treatment for various hematological malignancies and non-malignant hematological disorders. However, delayed platelet engraftment remains a frequent complication after transplantation and is associated with prolonged thrombocytopenia, increased bleeding risk, higher transfusion requirements, and extended hospitalization.
Romiplostim, a thrombopoietin receptor agonist (TPO-RA), promotes megakaryocyte proliferation, differentiation, and platelet production through activation of the thrombopoietin receptor (c-Mpl). Although romiplostim has been widely used in immune thrombocytopenia and chemotherapy-induced thrombocytopenia, its efficacy and safety in promoting platelet engraftment after allo-HSCT remain unclear.
The investigators retrospectively analyzed patients who underwent allo-HSCT at Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology between January 2025 to May 2026. Patients were categorized into a romiplostim group and a control group according to whether romiplostim was administered after transplantation.
To minimize baseline imbalance and potential confounding factors, propensity score matching (PSM) was performed at a 1:1 ratio.
The primary endpoint was time to platelet engraftment. Secondary endpoints included platelet recovery kinetics, transfusion requirements, transplant-related complications, and safety outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with AA, AL, MDS, PMF, or other hematologic diseases according to internationally accepted diagnostic criteria
- •Patients who underwent allo-HSCT during the study period
- •Patients with complete clinical characteristics, transplantation records, and follow-up data
排除标准
- •Primary graft failure;
- •Death before hematopoietic engraftment
- •Missing key clinical data;(4) Use of thrombopoietin receptor agonists other than romiplostim
研究组 & 干预措施
Romiplostim Group
Patients who received romiplostim after allogeneic hematopoietic stem cell transplantation for platelet engraftment.
Control Group
Patients who did not receive romiplostim after allogeneic hematopoietic stem cell transplantation.
结局指标
主要结局
Time to Platelet Recovery to ≥50×10⁹/L
时间窗: up to Day 100
Time from allogeneic hematopoietic stem cell transplantation (Day 0) to the first date of achieving platelet count ≥50×10⁹/L without transfusion support in the preceding 7 days.
次要结局
- Time to Platelet Engraftment(up to Day 100)
- Time to Neutrophil Engraftment(up to Day 60)
研究者
Donghua Zhang
Professor of Hematology
Tongji Hospital