Originally published as JCO Early Release 10.1200/JCO.2005.05.0401 on November 6 2006

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Clinical Efficacy of Lenalidomide in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia: Results of a Phase II Study

Asher Chanan-Khan, Kena C. Miller, Laurie Musial, David Lawrence, Swaminathan Padmanabhan, Kenichi Takeshita, Carl W. Porter, David W. Goodrich, Zale P. Bernstein, Paul Wallace, David Spaner, Alice Mohr, Catriona Byrne, Francisco Hernandez-Ilizaliturri, Cynthia Chrystal, Petr Starostik, Myron S. Czuczman

From the Departments of Medicine, Pharmacology and Therapeutics, Biostatistics, and Pathology, Roswell Park Cancer Institute, Buffalo, NY; Celgene Corporation, Summit, NJ; and Toronto Sunnybrook Regional Cancer Center, Toronto, Ontario, Canada

Address reprint requests to Asher Chanan-Khan, MD, Department of Medicine, Roswell Park Cancer Institute, Elm and Carlton St, Buffalo, NY 14263; e-mail: asher.chanan-khan{at}roswellpark.org

PURPOSE: Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have profound immune defects and limited treatment options. Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects, we conducted a phase II trial of this agent in CLL.

PATIENTS AND METHODS: Patients with relapsed or refractory B-cell CLL (B-CLL) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines. Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle. Response was assessed after each cycle. Patients were to continue treatment until disease progression, unacceptable toxicity, or complete remission. Rituximab was added to lenalidomide on disease progression.

RESULTS: Forty-five patients were enrolled, with a median age of 64 years. Sixty-four percent of the patients had Rai stage III or IV disease, and 51% were refractory to fludarabine. The overall response rate was 47%, with 9% of the patients attaining a complete remission. Fatigue, thrombocytopenia, and neutropenia were the most common adverse effects noted in 83%, 78%, and 78% of the patients, respectively.

CONCLUSION: Lenalidomide is clinically active in patients with relapsed or refractory B-CLL. These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder.

published online ahead of print at www.jco.org on November 6, 2006.

Supported by Celgene Corporation, Summit, NJ.

Presented in part at the XI International Workshop on Chronic Lymphocytic Leukemia, September 16–18, 2005, Brooklyn, NY; the 47th Annual Meeting of the American Society of Hematology, December 10–13, 2005, Atlanta, GA; and the 41st Annual Meeting of the American Society of Clinical Oncology, May 13–17, 2005, Orlando, FL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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