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.