Chronic lymphocytic leukemia (CLL) often responds to chemotherapy, but frequently recurs. Bendamustine and rituximab are chemotherapy drugs used to treat this disease. Patients may experience multiple recurrences, even with these treatments. Bendamustine and rituximab are 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 bendamustine and rituximab plus GS-1101 is more effective than bendamustine and rituximab alone in people with CLL that has persisted despite prior treatment. Patients will be randomly assigned to receive bendamustine/rituximab plus GS-1101 or bendamustine/rituximab plus a placebo.