A decrease in relative risk of disease progression was achieved with lenalidomide maintenance therapy in patients with chronic lymphocytic leukemia (CLL) who did not achieve minimal residual disease negative disease state after first-line chemoimmunotherapy, a study published in Lancet Haematology has shown.

For this double blind, phase 3 CLLM1 study, researchers randomly assigned 89 patients with CLL 2:1 to receive maintenance therapy with lenalidomide 5 mg or placebo. Eligible patients needed to have responded to first-line chemoimmunotherapy 2 to 5 months after completion, achieved a partial response after 4 or more cycles of first-line therapy, and were at high risk of early progression. High risk of progression was defined as having high or intermediate levels of minimal residual disease combined with an unmutated IGHV gene status or TP53 alteration.

After a median observation time of 17.9 months, the results of the study showed that the hazard ratio for progression-free survival (PFS) was 0.168 (95% CI, 0.074-0.379). Median PFS was 13.3 months (95% CI, 9.9-19.7) and not reached (95% CI, 32.3 – not evaluable) in the placebo and lenalidomide groups, respectively.

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Recruitment for the study was terminated prematurely due to poor accrual.

The most frequently reported adverse events were skin disorders, gastrointestinal disorders, infections, hematologic toxicities, and general disorders.

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The data suggests that lenalidomide is an effective option for maintenance therapy in high-risk patients with CLL who do not achieve minimal residual disease after first-line therapy. The authors of the study added that “the trial independently confirms the clinical significance of a novel, minimal residual disease-based algorithm to predict short progression-free survival, which might be incorporated in future clinical trials to identify candidates for additional maintenance treatment.”


1. Fink AM, Bahlo J, Robrecht S, et al. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study [published online September 12, 2017]. Lancet Haemato. doi: 10.1016/S2352-3026(17)30171-0