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 Indolent Non-Hodgkin Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 475
- 试验地点
- 141
- 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 addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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
- 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
- •Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following
- •Follicular lymphoma (FL) Grade 1, 2, or 3a
- •Small lymphocytic lymphoma (SLL)
- •Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
- •Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
排除标准
- •History of lymphoid malignancy other than those allowed per inclusion criteria.
- •Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •Prior treatment with bendamustine that was not effective.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Rituximab + Bendamustine + Idelalisib
Participants will receive rituximab + bendamustine + idelalisib.
干预措施: Rituximab (Drug)
Rituximab + Bendamustine + Idelalisib
Participants will receive rituximab + bendamustine + idelalisib.
干预措施: Idelalisib (Drug)
Rituximab + Bendamustine + Idelalisib
Participants will receive rituximab + bendamustine + idelalisib.
干预措施: Bendamustine (Drug)
Rituximab + Bendamustine + Placebo
Participants will receive rituximab + bendamustine + placebo.
干预措施: Rituximab (Drug)
Rituximab + Bendamustine + Placebo
Participants will receive rituximab + bendamustine + placebo.
干预措施: Bendamustine (Drug)
Rituximab + Bendamustine + Placebo
Participants will receive rituximab + bendamustine + placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
次要结局
- Overall Response Rate (ORR)
- Lymph Node Response Rate
- Overall Survival (OS)
- Complete Response Rate (CR)