At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Idelalisib, Rituximab, and 2 other interventions for Chronic Lymphocytic Leukemia. Completed, enrolled 416 participants across 106 sites in 18 countries.
Detailed Summary
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)
Study Details
Timeline
Interventions
Idelalisib 150 mg administered orally twice daily
Rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a maximum of 6 infusions
Bendamustine 70 mg/mg\^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Placebo to match idelalisib administered orally twice daily