Overview
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Status:
Completed
Completed
Trial end date:
2014-04-01
2014-04-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Gilead SciencesTreatments:
Idelalisib
Rituximab
Criteria
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.