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* Journal Articles uri icon

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  • 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.


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

publication date

  • June 2, 2016