TY - JOUR
T1 - Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia
T2 - Results of a phase II study
AU - Chanan-Khan, Asher
AU - Miller, Kena C.
AU - Musial, Laurie
AU - Lawrence, David
AU - Padmanabhan, Swaminathan
AU - Takeshita, Kenichi
AU - Porter, Carl W.
AU - Goodrich, David W.
AU - Bernstein, Zale P.
AU - Wallace, Paul
AU - Spaner, David
AU - Mohr, Alice
AU - Byrne, Catriona
AU - Hernandez-Ilizaliturri, Francisco
AU - Chrystal, Cynthia
AU - Starostik, Petr
AU - Czuczman, Myron S.
PY - 2006/12/1
Y1 - 2006/12/1
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.2005.05.0401
DO - 10.1200/JCO.2005.05.0401
M3 - Article
C2 - 17088571
AN - SCOPUS:33947243663
SN - 0732-183X
VL - 24
SP - 5343
EP - 5349
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 34
ER -