A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Rituximab for Patients with Previously Treated Chronic Lymphocytic Leukemia

Study Status

Open to Enrollment

Study Description

This is a clinical trial for people with previously treated chronic lymphocytic leukemia (CLL). The purpose of this study is to evaluate the effectiveness of the experimental drug Idelalisib (also called GS-1101, and formerly called CAL-101) combined with rituximab in treating CLL.

GS-1101 (CAL-101) is a pill designed to block some of the cell functions that cause CLL to grow and survive and may help control the disease. Rituximab is FDA-approved as a treatment for CLL. It is possible that giving rituximab together with GS-1101 may have more activity against the CLL disease process than giving rituximab alone.

Study participants will be randomly assigned to one of two treatment groups:

  • Group A: rituximab and GS-1101
  • Group B: rituximab and placebo (an inactive pill that looks like GS-1101 but contains no medicine)

After 24 weeks of therapy with rituximab and GS-1101 or placebo, participants will continue on GS-1101 or placebo as long as their CLL is controlled. If their CLL gets worse, participants may be able to take part in a separate extension study where they receive GS-1101 at a higher or lower dose. Thus, everyone who is treated in this study has an opportunity to receive active GS-1101, either in the main study or the extension study.

Disease Status and/or Stage

Previously Treated Chronic Lymphocytic Leukemia (CLL)

Sponsor

Gilead Sciences, Inc.

Key Eligibility

  • Men and women age 18 and older
  • Diagnosis of B-cell Chronic Lymphocytic Leukemia (CLL)
  • Previously treated for CLL
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Richard Furman, MD

Contact

Protocol ID

0116


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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