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 Indolent Non-Hodgkin Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 295
- 试验地点
- 103
- 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 effect of the addition of idelalisib to 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) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
- •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.
- •Received previous treatment with rituximab that was not effective.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Rituximab + idelalisib
Participants will receive rituximab + idelalisib.
干预措施: Idelalisib (Drug)
Rituximab + idelalisib
Participants will receive rituximab + idelalisib.
干预措施: Rituximab (Drug)
Rituximab + Placebo
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
干预措施: Placebo (Drug)
Rituximab + Placebo
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
干预措施: Rituximab (Drug)
Rituximab + Placebo
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
干预措施: Idelalisib (Drug)
结局指标
主要结局
Progression Free Survival
Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
次要结局
- Overall Response Rate
- Complete Response Rate
- Lymph Node Response Rate
- Overall Survival