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

Trial ID or NCT#

NCT01539512

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Caroline Berube
Caroline Berube
Hematologist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Jason Gotlib
Hematologist, Medical oncologist, Leukemia specialist, Hematologist-Oncologist
Professor of Medicine (Hematology)

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061