Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL CAL-101 GS 1101 PI3K GS-US-312-0117 idelalisib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants will receive idelalisib plus rituximab arm 2: Participants will receive placebo to match idelalisib plus rituximab

Interventions: intervention 1: Idelalisib intervention 2: Rituximab intervention 3: Placebo to match idelalisib
Intervention descriptions: intervention 1: Idelalisib 150 mg tablet administered orally twice daily intervention 2: Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter intervention 3: Placebo to match idelalisib administered orally twice daily

Protocol document: