Results of a phase II study of lenalidomide and rituximab for refractory/relapsed chronic lymphocytic leukemia.
Chronic lymphocytic leukemia (CLL) is an incurable disease in need of new therapeutic strategies. The immunomodulatory agent, lenalidomide, has shown activity as salvage therapy for CLL. In this phase II trial, we combined lenalidomide with rituximab in 25 patients (range, 41-79) with refractory/relapsed CLL. Lenalidomide was administered orally on escalating doses, with cycle 1 doses of 2.5mg daily on days 1-7, 5mg on days 8-14, and 10mg on days 15-21 followed by 7days off. On cycle 2 and beyond, lenalidomide was administered at 20mg daily on days 1-21. Rituximab was administered at 375mg/m(2) intravenously on a weekly basis for the first cycle starting on day 15 for 4 doses, with each cycle being 28days. Treatment was continued until disease progression or toxicity. Overall response rate was 45.8% on intent-to-treat and 61.1% in evaluable patients (all partial responses). Median time to treatment failure was 14.3 months for evaluable patients, and median overall survival was not reached. The most common grade 3/4 toxicity was neutropenia (72% of patients). The most common nonhematologic toxicity was infection (29% of patients). Lenalidomide combined with rituximab showed activity in heavily treated refractory CLL with an acceptable toxicity profile.
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States. Electronic address: julio.c.chavez@moffitt.org.
Julio C
JC
Chavez
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Miguel
M
Piris-Villaespesa
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Samir
S
Dalia
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
John
J
Powers
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Elyce
E
Turba
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Lisa
L
Nodzon
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Rami
R
Komrokji
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Lubomir
L
Sokol
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Frederick L
FL
Locke
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Jeffrey
J
Lancet
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Eduardo M
EM
Sotomayor
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Mohamed A
MA
Kharfan-Dabaja
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, United States.
Javier
J
Pinilla-Ibarz
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007239:Infections / Q000139:chemically induced; D000077269:Lenalidomide; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage*; D016879:Salvage Therapy / Q000379:methods* / Q000401:mortality; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives*
D000069283:Rituximab; D013792:Thalidomide; D000077269:Lenalidomide
CLL; Lenalidomide; Refractory; Rituximab