This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.
- Must have diagnosed Chronic Lymphocytic Leukemia (CLL)
- Otherwise normal organ function
- No previous treatment for CLL
- No active uncontrolled infection
- No allergies to Mannitol
All subjects will be required to come to the hospital every 4 weeks for blood draws and physical examinations. Subjects will have CT scans of the chest, neck, abdomen, and pelvis at the start of the study, 4 months of being on the study, 3 months after stopping any study drugs, and 2 years after being in the study. Subjects will have a bone marrow biopsy at the start of the study, 3 months after stopping any study drugs, and 2 years after being in the study.
Subjects will randomly be placed into one of three groups, or arms, of the study. Arm 1 will receive the standard chemotherapy regimen for this disease consisting of Bendamusting and Rituximab. Arm 2 will receive the study drug Ibrutinib alone. Arm 3 will receive the study drug Ibrutininb in combination with the FDA approved chemotherapy drug Rituximab. Subjects on Arm 1 will receive their chemotherapy intravenously in the hospital 2 days out of every 28 days. Subjects on Arm 2 will take study drug orally every day and log entries in a drug diary. Subjects on Arm 3 will take the study drug orally every day as well as receive Rituximab intravenously in the hospital every week. Subjects will be on study for at least 6 months unless disease progresses.
Subjects can participate in two optional portions of the study. One involving the completion of questionnaires to evaluate lifestyle and one involving the collection of additional blood samples for biological testing and storage for future research for this type of cancer or other health problems.