An individualized, dose-escalation schedule of lenalidomide plus chemotherapy may be a safe and effective strategy among patients with chronic lymphocytic leukemia (CLL), according to a study published in Haematologica.1

Although first-line treatment for elderly patients and patients unfit for fludarabine, cyclophosphamide, and rituximab (FCR) therapy, such as chlorambucil plus rituximab, are effective, they still face significant challenges including resistance/relapse, adverse events, and high costs. Previous studies have shown that lenalidomide may be effective, but due to its toxicity profile, its feasibility in combination therapy for CLL is in question.

For this phase 1/2 study, researchers enrolled 53 treatment-naive patients with CLL and treated them with 6 cycles of chlorambucil, rituximab, plus individual-dosed lenalidomide 2.5-10 mg (induction I), followed by 6 months of lenalidomide 10 mg monotherapy (induction II). The median follow-up was 27.0 months.

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Overall, 89% (47) and 68% (36) of patients were able to complete induction I and II, respectively.

Results showed that the overall response rate was 83%. The median progression-free survival (PFS) was 49 months, with 2- and 3-year PFS rates of 58% and 54%, respectively. The 2-year overall survival (OS) rate was 98%, and the 3-year OS rate was 95%.

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The most frequently observed hematologic adverse event was grade 3 to 4 neutropenia (73%). There were no instances of tumor lysis syndrome, and tumor flair reactions occurred in 5 patients (9%).

The authors concluded that this “study showed that triple treatment with [chlorambucil], rituximab and [lenalidomide] is an effective treatment in previously untreated elderly and FCR-unfit patients. Intensive monitoring is pivotal to minimize toxicity and ensure safety.”


  1. Kater AP, van Oers MHJ, van Norden Y, et al. Feasibility and efficacy of addition of individualized dose lenalidomide to chlorambucil and rituximab as first-line treatment in elderly and FCR-unfit patients with advanced chronic lymphocytic leukemia [published online August 16, 2018]. Haematologica. doi: 10.3324/haematol.2018.193854.