R-GEM-Lenalidomide versus R-GEM-P as second-line treatment of diffuse large B-cell lymphoma: results of the UK NRCI phase II randomised LEGEND trial

Andrea Kühnl, Clare Peckitt, Bijal Patel, Kirit M. Ardeshna, Marian P. Macheta, John Radford, Rod Johnson, Shankaranarayana Paneesha, Sarah Barton, Ian Chau, Ruwaida Begum, Nicola Valeri, Andrew Wotherspoon, Yong Du, Imene Zerizer, David Cunningham

Research output: Contribution to journalArticlepeer-review

Abstract

Outcome of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) remains poor, highlighting the need for novel treatment approaches. The multicentre randomised phase II LEGEND trial evaluated lenalidomide in combination with rituximab, methylprednisolone and gemcitabine (R-GEM-L) vs. standard R-GEM-P as second-line treatment of DLBCL. The study closed early to recruitment after the planned interim analysis failed to demonstrate a complete response (CR) rate of ≥ 40% in either arm. Among 34 evaluable patients, 7/18 (38.9%) achieved CR with R-GEM-L and 3/16 (18.8%) with R-GEM-P. Median event-free and overall survival was 3.5/3.8 months and 10.8/8.3 months for R-GEM-L and R-GEM-P, respectively. The incidence of grade ≥ 3 toxicities was 52% in R-GEM-L and 83% in R-GEM-P. Efficacy and tolerability of R-GEM-L seem comparable with R-GEM-P and other standard salvage therapies, but a stringent design led to early trial closure. Combination of lenalidomide with gemcitabine-based regimens should be further evaluated in r/r DLBCL.

Original languageEnglish
Pages (from-to)105-112
Number of pages8
JournalAnnals of Hematology
Volume99
Issue number1
Early online date27 Nov 2019
DOIs
Publication statusPublished - 1 Jan 2020

Keywords

  • DLBCL
  • Lenalidomide
  • Second-line therapy

Research Beacons, Institutes and Platforms

  • Manchester Cancer Research Centre

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