A Phase III Study of Bendamustine and Rituximab plus GS-1101 (CAL-101) or Placebo for Previously Treated Chronic Lymphocytic Leukemia

Protocol
12-189
Full Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Phase
III
Purpose

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.

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 that included a purine analog or bendamustine and a monoclonal antibody.
  • Patients’ CLL must have progressed within 3 years of completing the last therapy.
  • Patients must have recovered from the serious side effects of prior therapies.
  • This study is open to patients age 18 and 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