1. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.
- Author
-
Wendtner, Clemens-Martin, Hillmen, Peter, Mahadevan, Daruka, Bühler, Andreas, Uharek, Lutz, Coutré, Steven, Frankfurt, Olga, Bloor, Adrian, Bosch, Francesc, Furman, Richard R., Kimby, Eva, Gribben, John G., Gobbi, Marco, Dreisbach, Luke, Hurd, David D., Sekeres, Mikkael A., Ferrajoli, Alessandra, Shah, Sheetal, Zhang, Jennie, and Moutouh-de Parseval, Laure
- Subjects
LYMPHOCYTIC leukemia ,LEUKEMIA ,FEBRILE neutropenia ,PRELEUKEMIA ,FLUDARABINE ,DRUG therapy ,PATIENTS - Abstract
Based on clinical activity in phase 2 studies, lenalidomide was evaluated in a phase 2/3 study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Following tumor lysis syndrome (TLS) complications, the protocol was amended to a phase 1 study to identify the maximum tolerated dose-escalation level (MTDEL). Fifty-two heavily pretreated patients, 69% with bulky disease and 48% with high-risk genomic abnormalities, initiated lenalidomide at 2.5 mg/day, with dose escalation until the MTDEL or the maximum assigned dose was attained. Lenalidomide was safely titrated to 20 mg/day; the MTDEL was not reached. Most common grade 3-4 adverse events were neutropenia and thrombocytopenia; TLS was mild and rare. The low starting dose and conservative dose escalation strategy resulted in six partial responders and 30 patients obtaining stable disease. In summary, lenalidomide 2.5 mg/day is a safe starting dose that can be titrated up to 20 mg/day in patients with CLL. [ABSTRACT FROM AUTHOR]
- Published
- 2012
- Full Text
- View/download PDF