Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial

Clemens M. Wendtner, Michael Hallek, Graeme A.M. Fraser, Anne Sophie Michallet, Peter Hillmen, Jan Dürig, Matt Kalaycio, John G. Gribben, Stephan Stilgenbauer, Andreas Buhler, Thomas J. Kipps, Brendan Purse, Jennie Zhang, Sabine De Bedout, Jay Mei, Asher Chanan-Khan

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13 Scopus citations

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 languageEnglish (US)
Pages (from-to)1291-1299
Number of pages9
JournalLeukemia and Lymphoma
Volume57
Issue number6
DOIs
StatePublished - Jun 2 2016

Keywords

  • CLL
  • Clinical trial
  • lenalidomide
  • phase II

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Wendtner, C. M., Hallek, M., Fraser, G. A. M., Michallet, A. S., Hillmen, P., Dürig, J., Kalaycio, M., Gribben, J. G., Stilgenbauer, S., Buhler, A., Kipps, T. J., Purse, B., Zhang, J., De Bedout, S., Mei, J., & Chanan-Khan, A. (2016). Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial. Leukemia and Lymphoma, 57(6), 1291-1299. https://doi.org/10.3109/10428194.2015.1128540