Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)
研究概览
简要总结
Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed
详细描述
Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days.
Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 to 18 years
- •solid malignancy
- •Lansky score >70%
- •12 to 18 days since the beginning of the last chemotherapy cycle
- •no administration of any hematopoietic growth factor in the previous 8 days
排除标准
- •clinical or biological conditions precluding the mobilization or collection procedure
结局指标
主要结局
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)
时间窗: less than 3 blood volume processed
次要结局
- Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells(at least 5*10e6CD34cells)