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.
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.
Authors: Todd A Fehniger; Sarah Larson; Kathryn Trinkaus; Marilyn J Siegel; Amanda F Cashen; Kristie A Blum; Timothy S Fenske; David D Hurd; Andre Goy; Stephanie E Schneider; Catherine R Keppel; Nina D Wagner-Johnston; Kenneth R Carson; Nancy L Bartlett Journal: Blood Date: 2011-09-21 Impact factor: 22.113
Authors: Bruce D Cheson; John C Byrd; Kanti R Rai; Neil E Kay; Susan M O'Brien; Ian W Flinn; Adrian Wiestner; Thomas J Kipps Journal: J Clin Oncol Date: 2012-07-09 Impact factor: 44.544
Authors: Deborah M Stephens; Amy S Ruppert; Kristie Blum; Jeffrey Jones; Joseph M Flynn; Amy J Johnson; Jia Ji; Mitch A Phelps; Michael R Grever; John C Byrd Journal: Haematologica Date: 2012-01-22 Impact factor: 9.941
Authors: John C Byrd; Amy S Ruppert; Nyla A Heerema; Alese E Halvorson; Eva Hoke; Mitchell R Smith; John E Godwin; Stephen Couban; Todd A Fehniger; Michael J Thirman; Martin S Tallman; Frederick R Appelbaum; Richard M Stone; Sue Robinson; Julie E Chang; Sumithra J Mandrekar; Richard A Larson Journal: Blood Adv Date: 2018-07-24