Protocol
12-160
Full Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Purpose
Chronic lymphocytic leukemia (CLL) often responds to chemotherapy, but frequently recurs. Rituximab is one of the chemotherapy drugs used to treat this disease. Patients may experience multiple recurrences, even with rituximab treatment. Rituximab is given intravenously (by vein).
GS-1101 (CAL-101) is an investigational drug that has been shown to be effective against CLL in prior clinical trials. It works by inhibiting an enzyme called PI3 kinase, which fuels cancer growth. It is given orally (by mouth).
In this phase III study, researchers want to determine if rituximab plus GS-1101 is more effective than rituximab alone in people with CLL that has persisted despite prior treatment. Patients will be randomly assigned to receive rituximab plus GS-1101 or rituximab plus a placebo.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have B-cell CLL that has been previously treated with standard therapies.
- At least 3 weeks must have passed since completion of prior therapy and entry into the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Andrew Zelenetz at 212-639-2656.
Disease(s)
Leukemia
Leukemia: Chronic Lymphocytic Leukemia
Locations
Related Diseases
