A Randomized, Open-label, Two-arm Parallel Group, Comparative Study for Assessing the Clinical Benefit of Subcutaneous Injection of Plerixafor Plus G-CSF for Mobilization and Collection of Peripheral Hematopoietic Stem Cells in Japanese Patients With Non-Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
研究概览
简要总结
Primary Objective:
To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in 4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.
Secondary Objectives:
- To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL participants.
- To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
- To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.
详细描述
Total study duration for a participant can be approximately up to 68 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
granulocyte colony-stimulating factor alone
G-CSF administered up to 8 days
干预措施: Filgrastim (Drug)
granulocyte colony-stimulating factor plus plerixafor
G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
干预措施: plerixafor GZ316455 (Drug)
granulocyte colony-stimulating factor plus plerixafor
G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
干预措施: Filgrastim (Drug)
结局指标
主要结局
Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
时间窗: Day 5 to Day 8 of the apheresis/treatment period
次要结局
- Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells(Day 5 to Day 8 of the apheresis/treatment period)
- Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells(Day 5 to Day 8 of the apheresis/treatment period)
- The relative increase (ratio) of peripheral blood (PB) CD34+ cell count (cells/μL)(From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only)
- Change from baseline in clinical laboratory measurements(Up to 68 days)
- Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis(Day 5 to Day 8 of the apheresis/treatment period)
- Total number of CD34+ cells/kg collected over up to 4 apheresis(Day 5 to Day 8 of the apheresis/treatment period)
- Number of participants with adverse events(Up to 68 days)