A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

This is 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 Chronic Lymphocytic Leukemia.

Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to
receive either Idelalisib or placebo. All subjects will be administered rituximab. Subjects
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.

Inclusion:

- Adult subjects with previously treated recurrent CLL who have measurable
lymphadenopathy

- Require therapy for CLL

- Have experienced CLL progression <24 months since the completion of the last prior
therapy

- Currently not sufficiently fit to receive cytotoxic therapy because of
chemotherapy-induced bone marrow damage or comorbidities.