This phase II trial studies how well bendamustine hydrochloride and rituximab followed by rituximab and lenalidomide work in treating patients with previously untreated chronic lymphocytic leukemia or small cell lymphocytic lymphoma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Monoclonal antibodies, such as rituximab, block cancer growth in different ways by targeting certain cells. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving bendamustine hydrochloride and rituximab followed by rituximab and lenalidomide may kill more cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01754857.
PRIMARY OBJECTIVES:
I. The primary objective is progression-free survival for patients entering the maintenance therapy phase with rituximab and lenalidomide after induction therapy with bendamustine (bendamustine hydrochloride) and rituximab (beginning cycle 1, day 1 of maintenance chemotherapy).
SECONDARY OBJECTIVES:
I. To determine objective response rates (complete response [CR] + partial response [PR]).
II. To determine toxicities observed with induction chemotherapy and maintenance therapy.
III. To determine overall survival.
OUTLINE:
INDUCTION CHEMOIMMUNOTHERAPY: Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1 and 2 and rituximab IV on day 1 (up to day 5 of cycle 1). Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving CR, PR, or stable disease proceed to maintenance therapy. Patients with objective response after 4 cycles are eligible to proceed to maintenance therapy if ongoing induction therapy is likely associated with unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 6-12 weeks after completion of induction chemoimmunotherapy, patients receive rituximab IV on day 1 of every odd-numbered cycle and lenalidomide orally (PO) daily on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone. Patients experiencing excessive toxicity from rituximab may continue maintenance therapy with lenalidomide alone.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years and then annually for 5 years.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorJulie E. Chang
