Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia LEUKEMIA & LYMPHOMA Wendtner, C., Hillmen, P., Mahadevan, D., Buehler, A., Uharek, L., Coutre, S., Frankfurt, O., Bloor, A., Bosch, F., Furman, R. R., Kimby, E., Gribben, J. G., Gobbi, M., Dreisbach, L., Hurd, D. D., Sekeres, M. A., Ferrajoli, A., Shah, S., Zhang, J., Moutouh-de Parseval, L., Hallek, M., Heerema, N. A., Stilgenbauer, S., Chanan-Khan, A. A. 2012; 53 (3): 417-423


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.

View details for DOI 10.3109/10428194.2011.618232

View details for Web of Science ID 000300451100012

View details for PubMedID 21879809