Infusion of Recombinant Human Granulocyte Colony Stimulating Factor Mobilized Peripheral Harvest for Poor Engraftment After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- hematological response
研究概览
简要总结
Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral cell harvest for poor graft function.
详细描述
Poor graft function (PGF) is a common complication after allogeneic stem cell transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly understood. Infusion of donor peripheral cell harvest was effective for some patients with PGF in our preliminary study.The peripheral cell harvest was aphaeresis on the fourth or fifth day after mobilization with recombinant human granulocyte colony stimulating factor. Hematogical response was assessed at 30 days after infusion. Good response was defined as neutrophil > 1.0×109/l without G-CSF support for at least 3 consecutive days, and persistent platelet >20×109/l without transfusion for at least 7 days. Otherwise, poor response was defined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients received allogeneic stem cell transplantation;diagnosis of PGF after HSCT; without concurent GVHD,RELAPSE of underlying disease.
排除标准
- •age<14 years;active GVHD;relapse of underlying disease
结局指标
主要结局
hematological response
时间窗: 30 days after infusion
Hematogical response was assessed at 30 days after infusion. Good response was defined as neutrophil \> 1.0×109/l without G-CSF support for at least 3 consecutive days, and persistent platelet \>20×109/l without transfusion for at least 7 days. Otherwise, poor response was defined.
次要结局
未报告次要终点
研究者
Xiaojun Huang,MD
Peking University Institute of Hematology
Peking University People's Hospital