A decrease in the relative risk of disease progression was observed with lenalidomide maintenance therapy in patients with chronic lymphocytic leukemia (CLL) who did not reach a minimal residual disease state after first-line chemoimmunotherapy, according to a study published in Lancet Haematology.1
For the phase 3 CLLM1 study (ClinicalTrials.gov Identifier: NCT01556776), researchers randomly assigned 89 patients with CLL 2:1 to receive maintenance therapy with lenalidomide 5 mg or placebo.
After a median observation time of 17.9 months, results 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.
Recruitment for the study was terminated prematurely due to poor accrual.
The most frequently reported adverse events were skin disorders, gastrointestinal disorders, infections, and hematologic toxicities.
The data suggest that lenalidomide is an effective option for maintenance therapy in high-risk patients with CLL who do not reach minimal residual disease after first-line therapy.
The authors concluded that this “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.”
- 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. Lancet Haematol. 2017;4(10):e475-e486. doi: 10.1016/S2352-3026(17)30171-0
This article originally appeared on Cancer Therapy Advisor