Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial
Abstract
Randomised, double-blind, placebo-controlled, phase 3 trial (CONTINUUM), adult patients with chronic lymphocytic leukaemia, who had been treated with two lines of therapy (with at least a partial response after second-line therapy). Between 2009 and 2015, 314 patients were enrolled and randomly assigned to receive either lenalidomide (n=160) or placebo (n=154).
Progression-free survival was significantly longer in the lenalidomide group (median 33.9 months, 95% CI 25.5-52.5) than in the placebo group (9.2 months, 7.4-13.6; HR 0.40, 95% CI 0.29-0.55; p<0.0001). The most common grade 3 or 4 adverse events included neutropenia (94 [60%] in the lenalidomide group vs 35 [23%] in the placebo group), thrombocytopenia (26 [17%] vs ten [6%]), and diarrhoea (13 [8%] vs one [<1%]).
Chemoimmunotherapy followed by lenalidomide maintenance could be an effective treatment option for patients with chronic lymphocytic leukaemia who do not have access to kinase inhibitors.