A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 311
- 试验地点
- 90
- 主要终点
- Progression-Free Survival
研究概览
简要总结
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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
- Double (Participant, 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
- •Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
- •No prior therapy for CLL other than corticosteroids for disease complications
- •CLL that warrants treatment
- •Presence of measurable lymphadenopathy
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
排除标准
- •Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
- •Known presence of myelodysplastic syndrome
- •Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
- •Ongoing liver injury
- •History of non-infectious pneumonitis
- •Ongoing inflammatory bowel disease
- •History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- •Ongoing immunosuppressive therapy other than corticosteroids
- •Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
干预措施: Idelalisib (Drug)
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
干预措施: Bendamustine (Drug)
Idelalisib+bendamustine+rituximab
Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
干预措施: Rituximab (Drug)
Placebo+bendamustine+rituximab
Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
干预措施: Bendamustine (Drug)
Placebo+bendamustine+rituximab
Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
干预措施: Rituximab (Drug)
Placebo+bendamustine+rituximab
Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Up to 22 months
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
次要结局
- Overall Response Rate(Up to 22 months)
- Minimal Residual Disease Negativity Rate at Week 36(Up to 22 months)
- Overall Survival(Up to 22 months)
- Nodal Response Rate(Up to 22 months)
- Complete Response Rate(Up to 22 months)