This phase 2 clinical trial will test the effectiveness of bendamustine (Treanda) and rituximab (Rituxan) induction therapy followed by rituximab and lenalidomide (Revlimid) maintenance therapy in patients with previously untreated chronic lymphocytic leukemia (CLL). The primary outcome will be measured by the time to disease progression. The trial is being conducted at the University of Wisconsin, Madison.
The details
Bendamustine is a chemotherapy drug commonly used to treat lymphoma. Rituximab is an immunotherapy that uses the body’s own immune system to identify and kill cancerous B-cells. It is an antibody (a protein in the immune system) that binds to a protein found on B-cells, which alerts other parts of the immune system to attack. Lenalidomide is another chemotherapy. It is unclear whether bendamustine andrituximabas an induction (first) therapy followed by a rituximab and lenalidomide maintenance (long-term) therapy will effectively kill cancer cells in patients with CLL and prevent the return of cancer.
The study will examine the time to disease progression for up to 30 months. Side effects, survival rate, and response rate will also be observed.
Who are they looking for?
This trial is recruiting 32 patients with CLL. Patients must not have undergone any prior chemotherapy, but single-agent rituximab use is allowed. Patients with a history of prior cancers should be disease free for at least 2 years. Candidates cannot have a history of CLL involvement with the central nervous system. Patients should have adequate liver and kidney function.
How will it work
During the induction treatment, patients will receive intravenous (through IV into a vein) bendamustineon days 1 and 2 and rituximabon day 1 of each 28-day cycle for up to 6 cycles. Patients who respond will move on to receive the maintenance therapy starting 6 to 12 weeks after the induction treatment. Intravenous rituximab will be given on day 1 of every odd numbered cycle (28-day cycle), and lenalidomide will be taken every day by mouth for up to 24 cycles.
