The results of a phase 2 study of lenalidomide plus rituximab in patients with previously untreated indolent lymphoma were presented at the American Society of Clinical Oncology annual meeting in June 2011. Investigators at MD Anderson Cancer Center treated 75 patients (41 with follicular lymphoma, 19 with marginal zone lymphoma, 15 with chronic lymphocytic leukemia) with the combination and found that 90% of patients responded, with 66% achieving a complete response. Treatment was generally well tolerated, with only 5 patients stopping due to toxicity.
These results are exciting due both to the promising response rate and the fact that cytotoxic chemotherapy was not a part of the treatment regimen: Lenalidomide is an immunomodulatory agent and rituximab is a biologic agent/monoclonal antibody.
Currently, the CALGB is conducting a similar phase 2 trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. The trial is being led by Dr. Rebecca Elstrom at Weill Cornell Medical Center and will provide important confirmatory evidence in a larger group of patients treated at multiple centers around the country. (Update: this study is closed to enrollment.)
Dr. Jia Ruan at Weill Cornell is leading a study of lenalidomide plus rituximab as front-line therapy for patients with previously untreated mantle cell lymphoma (click here for more information on this trial).
A phase 3 trial comparing lenalidomide plus rituximab to chemotherapy plus rituximab in patients with previously untreated follicular lymphoma is being considered in Europe.