Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia

Clemens Martin Wendtner, Peter Hillmen, Daruka Mahadevan, Andreas Bhler, Lutz Uharek, Steven Coutré, Olga Frankfurt, Adrian Bloor, Francesc Bosch, Richard R. Furman, Eva Kimby, John G. Gribben, Marco Gobbi, Luke Dreisbach, David D. Hurd, Mikkael A. Sekeres, Alessandra Ferrajoli, Sheetal Shah, Jennie Zhang, Laure Moutouh-De ParsevalMichael Hallek, Nyla A. Heerema, Stephan Stilgenbauer, Asher A. Chanan-Khan

Research output: Contribution to journalArticle

50 Scopus citations

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 34 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.

Original languageEnglish (US)
Pages (from-to)417-423
Number of pages7
JournalLeukemia and Lymphoma
Volume53
Issue number3
DOIs
StatePublished - Mar 1 2012

Keywords

  • Chronic lymphocytic leukemia
  • Dose escalation
  • Lenalidomide
  • Phase 1
  • Relapsed or refractory

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Wendtner, C. M., Hillmen, P., Mahadevan, D., Bhler, A., Uharek, L., Coutré, 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., ... Chanan-Khan, A. A. (2012). Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leukemia and Lymphoma, 53(3), 417-423. https://doi.org/10.3109/10428194.2011.618232