A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 104
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
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
- Triple (Participant, Care Provider, Investigator)
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
- •Previously treated recurrent CLL
- •Measurable lymphadenopathy
- •Requires therapy for CLL
- •Has experienced CLL progression < 36 months since the completion of the last prior therapy
排除标准
- •Recent history of a major non-CLL malignancy
- •Evidence of an ongoing infection
- •CLL refractory to bendamustine
- •Concurrent participation in another therapeutic clinical trial
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab
干预措施: Idelalisib (Drug)
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab
干预措施: Rituximab (Drug)
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab
干预措施: Bendamustine (Drug)
Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab
干预措施: Rituximab (Drug)
Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab
干预措施: Bendamustine (Drug)
Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab
干预措施: Placebo to match idelalisib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 84 months
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
次要结局
- Complete Response Rate(Up to 84 months)
- Overall Response Rate (ORR)(Up to 84 months)
- Lymph Node Response Rate(Up to 84 months)
- Overall Survival(Up to 84 months)