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

Not Recruiting

Trial ID: NCT01539512

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

Stanford Investigator(s)

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Jason Gotlib

Professor of Medicine (Hematology)

Eligibility


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.

Intervention(s):

drug: Idelalisib

drug: Rituximab

drug: Placebo to match idelalisib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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