Abstract
The objective of this study was to evaluate the safety and efficacy of different lenalidomide starting doses in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). CLL patients were randomized to receive lenalidomide at initial doses of 5, 10, or 15 mg/d (N = 103). Doses were escalated by 5 mg every 28-d up to a maximum of 25 mg/d; dose reductions in up to 5 mg decrements were permitted. The most common grade ≥3 adverse events (AEs) were neutropenia and thrombocytopenia. Ten patients died during therapy (four deaths considered as related to lenalidomide); 12 patients experienced second primary malignancies. The most common cause for treatment discontinuation was AEs. Overall response rates were similar across arms. Progression-free survival and overall survival rates were longer in patients who escalated treatment (to 15 or 20 mg/d) versus those who did not. Lower starting doses allowed subsequent dose escalation of lenalidomide while maintaining an acceptable tolerability profile in patients with relapsed/refractory CLL.
Original language | English (US) |
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Pages (from-to) | 1291-1299 |
Number of pages | 9 |
Journal | Leukemia and Lymphoma |
Volume | 57 |
Issue number | 6 |
DOIs | |
State | Published - Jun 2 2016 |
Keywords
- CLL
- Clinical trial
- lenalidomide
- phase II
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research