A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS 1101 (CAL 101) in Combination with Rituximab for Patients with Previously Treated Chronic Lymphocytic Leukemia
Update: this study is closed to enrollment.
The Weill Cornell Lymphoma Program is now enrolling patients in a new clinical trial for people with previously treated Chronic Lymphocytic Leukemia (CLL). The sponsor is Gilead Sciences, and the principal investigator at Weill Cornell is Dr. Richard Furman. For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at firstname.lastname@example.org.
The study will evaluate the effectiveness of the experimental drug GS-1101 (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)
All study participants will receive rituximab via infusion 8 times over 24 weeks: Day 1, then Weeks 2, 4, 6, 8, 12, 16 and 20.
Participants will take GS-1101 or placebo twice daily for 24 weeks.
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.