Primary Objective:

The primary objective of the study will be to determine if maintenance therapy with Lenalidomide improves response rates following induction therapy with Bendamustine/Rituximab.

 

Secondary Objective: The secondary objective of the study will be to evaluate for toxicities related to the maintenance therapy.

 

The study will be a single institution nonrandomized phase II study. Patients with a diagnosis of CLL based on NCI criteria that have completed induction chemotherapy with six cycles of bendamustine 90mg/m² on days 1 and 2 and rituximab 375mg/m² (BR) on day 1 every 28 days will be eligible for the study. Please see section 5.2 on patient screening and eligibility for additional inclusion and exclusion criteria. The induction therapy may be done by the patient’s primary oncologist or at Smilow Cancer Hospital at Yale. Response to induction therapy in order to determine complete response (CR), partial response (PR), and stable disease will be determined by flow cytometry and cytogenetics three months following completion of BR. Patients with stable disease or those who have achieved a partial response three months after completion of the induction therapy will go on to receive maintenance therapy with single agent Lenalidomide. Patients may start the maintenance therapy up to six months after completion of the induction therapy. Prior to enrollment in the study each patient will have a complete blood count, immunophenotyping of peripheral blood lymphocytes, comprehensive metabolic panel, quantitative immunoglobulins, and bone marrow with flow cytometry and cytogenetics (bone marrow-optional). Please see section 2 for the schedule of study assessments. The Lenalidomide will start at a dose of 5mg daily on days 1-21 every 28 days. If the patient tolerates the dose of 5mg for the first cycle, the dose will be increased to 10mg at the start of cycle 2. Therapy will continue for 12 cycles in the absence of disease progression or unacceptable toxicities. Patients will be assessed prior to each cycle of Lenalidomide for toxicity via clinical examination and laboratory analysis. Flow cytometry of the peripheral blood will be

monitored every three months. Response will be assessed using the NCI working group guidelines for complete response, partial response, stable disease, and progressive disease.