Lenalidomide induced clinically meaningful antitumor activity among patients with relapsed or recurrent aggressive adult T-cell leukemia/lymphoma (ATL) with an acceptable safety profile, according to a study published in the Journal of Clinical Oncology.1

Only a handful of treatment regimens are recommended for the treatment of ATL, and prognosis for the disease remains poor.

Because lenalidomide has demonstrated preliminary antitumor activity in patients with relapsed ATL in a phase 1 study, researchers evaluated the efficacy and safety of single-agent lenalidomide among patients with relapsed or recurrent ATL.

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For the ATLL-02 study (ClinicalTrials.gov Identifier: NCT01724177), investigators enrolled 26 patients aged 20 years or older with acute, lymphoma, or unfavorable chronic subtype ATL, who had received at least 1 prior systemic chemotherapy regimen for ATL and achieved stable disease or better with their last therapy prior to relapse or recurrence.

All participants received lenalidomide orally daily until disease progression or unacceptable toxicity.

Results showed an objective response rate of 42% (95% CI, 23-63), which included 4 complete responses and 1 unconfirmed complete response. The rate of patients achieving stable disease or better was 73%.

Median progression-free survival and overall survival were 3.8 months and 20.3 months, respectively.

The most common grade 3 or worse adverse events were neutropenia, leukopenia, lymphopenia, and thrombocytopenia, all of which were manageable and reversible. Nine patients reported serious adverse events, with all resolving except in 2 cases.

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Despite these encouraging findings, the authors note that this study is limited by its small sample size and enrollment of patients with 3 different clinical subtypes of ATL. Prior therapies may have also affected the results.                              


  1. Ishida T, Fujiwara H, Nosaka K, et al. Multicenter phase II study of lenalidomide in relapsed or recurrent adult T-cell leukemia/lymphoma: ATLL-002. J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.7732 [Epub ahead of print]