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