NCT00364468已完成2 期
A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 6
- 主要终点
- To compare the duration of severe neutropenia
研究概览
简要总结
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as malignant lymphoma
- •patients who were refractory to anthracycline or anthraquinone containing chemotherapy
- •patients who are going to receive ESHAP or CHASE treatment regimen
- •ECOG performance status =< 2
- •patients who have appropriate bone marrow, hepatic and renal functions
- •written informed consent
排除标准
- •double cancer
- •history of bone marrow transplantation or PBSCT
- •more than 2 prior chemotherapy regimens
- •primary hematologic disease such as myelodysplastic syndrome
- •previous radiotherapy within 4 weeks of enrollment
- •woman of childbearing potential who were either pregnant, breast feeding
- •patients who participated in other clinical trials within the last 4 weeks of enrollment
结局指标
主要结局
To compare the duration of severe neutropenia
次要结局
未报告次要终点
研究者
研究点 (6)
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