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Clinical Trial
. 2020 Jan;99(1):105-112.
doi: 10.1007/s00277-019-03842-4. Epub 2019 Nov 27.

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  1   2 , Clare Peckitt  1 , Bijal Patel  1 , Kirit M Ardeshna  3 , Marian P Macheta  4 , John Radford  5 , Rod Johnson  6 , Shankaranarayana Paneesha  7 , Sarah Barton  1   8 , Ian Chau  1 , Ruwaida Begum  1 , Nicola Valeri  9 , Andrew Wotherspoon  1 , Yong Du  1 , Imene Zerizer  1 , David Cunningham  10
Affiliations
Clinical Trial

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 et al. Ann Hematol. 2020 Jan.

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.

Keywords: DLBCL; Lenalidomide; Second-line therapy.

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