In combination with lenalidomide, rituximab exhibited activity and acceptable toxicity profile for heavily pretreated patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to a study published in the journal Leukemia Research.1
For this phase 2 trial, investigators enrolled 25 patients ranging from 41 to 79 years. All participants received lenalidomide 2.5 mg orally on days 1 to 7, 5 mg on days 8 to 14, and 10 mg on days 15 to 21, followed by 7 days without treatment. For subsequent cycles, patients received lenalidomide at a dose of 20 mg daily on days 1 to 21.
Rituximab was given at an intravenous dose of 375 mg/m2 weekly on day 15 for 4 doses of each 28-day cycle. Treatment was given until disease progression or unacceptable toxicity.
The overall response rate was 45.8%, and 61.1% among evaluable patients; all responses were partial responses. Median time to treatment failure was 14.3 months; median overall survival had not yet been reached.
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The most common grade 3 to 4 treatment-related adverse event was neutropenia, which was observed in nearly 75% of patients. The most frequently reported nonhematologic toxicity was infection (29%).
- Chavez JC, Piris-Villaespesa M, Dalia S, et al. Results of a phase II study of lenalidomide and rituximab for refractory/relapsed chronic lymphocytic leukemia. Leuk Res. 2016;47:78-83.