A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 71
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Idelalisib + rituximab
Participants will receive idelalisib plus rituximab
干预措施: Idelalisib (Drug)
Idelalisib + rituximab
Participants will receive idelalisib plus rituximab
干预措施: Rituximab (Drug)
Placebo + rituximab
Participants will receive placebo to match idelalisib plus rituximab
干预措施: Rituximab (Drug)
Placebo + rituximab
Participants will receive placebo to match idelalisib plus rituximab
干预措施: Placebo to match idelalisib (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Up to 17 months
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
次要结局
- Overall Response Rate(Up to 17 months)
- Lymph Node Response Rate(Up to 17 months)
- Overall Survival(Up to 17 months)
- Complete Response Rate(Up to 17 months)