BUFFALO, NY -- Patients treated with lenalidomide for relapsed chronic lymphocytic leukemia (CLL) or disease that no longer responds to chemotherapy have experienced a major response to therapy, according to a phase II study conducted by Asher Chanan-Khan, MD, Department of Medicine, Roswell Park Cancer Institute (RPCI). The results are published in the December 1 issue of the Journal of Clinical Oncology.

"Chronic lymphocytic leukemia is the most common hematologic malignancy in the western hemisphere," according to Dr. Chanan-Khan, "and remains incurable." While several phase II studies have demonstrated improved clinical response to chemotherapy alone, or combined with the monoclonal antibody rituximab, relapse is inevitable and treatment options at that point are limited.

Lenalidomide is a novel immune modulating, non-chemotherapy, cancer drug that is chemically similar to thalidomide, but is more potent in the laboratory and appears to lack some of the more common side effects of thalidomide. Anticancer activity of this agent has been reported in various malignant disorders, including multiple myeloma and myelodysplastic syndrome.

In this phase II study the first to report clinical activity of lenalidomide in patients with CLL 45 patients with immunophenotypically diagnosed B-CLL were treated with a daily dose of 25 mg of lenalidomide. Major clinical responses were seen in 21 (47%) of the patients, with four achieving complete response and 17 achieving a partial response; all with a predictable and manageable safety profile. The most common side effects included fatigue, neutropenia and thrombocytopenia.

"Collectively, these data provide strong support for further pursuit of lenalidomide in confirmatory clinical studies that are now open at Roswell Park and other cancer centers in the country," notes Dr. Chanan-Khan.