Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 主要终点
- percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
研究概览
简要总结
Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state 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 2 blood volume processed)
详细描述
Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days.
Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)
Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording
Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 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%
- •more than 17 days since the beginning of the last chemotherapy cycle
- •absolute neutrophil count (ANC) greater than 1×109/l
- •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 2 blood volume processed)
次要结局
- Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells