Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: Data from the prospective, multicenter phase-II CLL-009 trial

A. Bühler, C. M. Wendtner, T. J. Kipps, L. Rassenti, G. A.M. Fraser, A. S. Michallet, P. Hillmen, J. Dürig, S. A. Gregory, M. Kalaycio, T. Aurran-Schleinitz, L. Trentin, J. G. Gribben, A. Chanan-Khan, B. Purse, J. Zhang, S. De Bedout, J. Mei, M. Hallek, S. Stilgenbauer

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13 Scopus citations

Abstract

Efficacy of lenalidomide was investigated in 103 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated on the prospective, multicenter randomized phase-II CLL-009 trial. Interphase cytogenetic and mutational analyses identified TP53 mutations, unmutated IGHV, or del(17p) in 36/96 (37.5%), 68/88 (77.3%) or 22/92 (23.9%) patients. The overall response rate (ORR) was 40.4% (42/104). ORRs were similar irrespective of TP53 mutation (36.1% (13/36) vs 43.3% (26/60) for patients with vs without mutation) or IGHV mutation status (45.0% (9/20) vs 39.1% (27/68)); however, patients with del(17p) had lower ORRs than those without del(17p) (21.7% (5/22) vs 47.1% (33/70); P=0.049). No significant differences in progression-free survival and overall survival (OS) were observed when comparing subgroups defined by the presence or absence of high-risk genetic characteristics. In multivariate analyses, only multiple prior therapies (≥3 lines) significantly impacted outcomes (median OS: 21.2 months vs not reached; P=0.019). This analysis indicates that lenalidomide is active in patients with relapsed/refractory CLL with unfavorable genetic profiles, including TP53 inactivation or unmutated IGHV.

Original languageEnglish (US)
Article numbere404
JournalBlood cancer journal
Volume6
DOIs
StatePublished - Mar 11 2016

ASJC Scopus subject areas

  • Hematology
  • Oncology

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