NCT00055146已完成2 期
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 41
- 试验地点
- 27
- 主要终点
- Objective Clinical Response
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV.
- •Patients must have received at least one prior purine analogue-based chemotherapy regimen.
- •ECOG Performance Status of 0, 1, or
- •Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends.
排除标准
- •Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-
- •Received any therapy for CLL within 35 days prior to study entry.
结局指标
主要结局
Objective Clinical Response
次要结局
- Time-to-Progression
- Duration of response
研究者
研究点 (27)
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