The maximum tolerated dose and schedule for lenalidomide treatment in patients with previously treated aggressive, adult T-cell leukemia-lymphoma may be 25 mg/day given continuously, according to a Japanese population study published in The Lancet Haematology.1

Researchers led by Michinori Ogura, MD, of the Nagoya Daini Red  Cross Hospital in Aichi, Japan, conducted a phase 1 study of 14 patients with documented diagnosis of aggressive adult T-cell leukemia-lymphoma or other peripheral T-cell lymphoma subtypes from 6 centers in Japan who were 20 years or older with Eastern Cooperative Oncology Group performance status of 0 to 2.

Primary endpoint was the identification of a maximum tolerated dose of lenalidomide, with analyses performed per protocol for efficacy and in the intent-to-treat population for safety.

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Among 13 patients who were assessable for receiving lenalidomide, dose-limiting toxic effects were reported in 3 patients during cycle 1, 1 grade 3 QT prolongation on electrocardiogram, 1 grade 3 fatigue, and 1 grade 4 thrombocytopenia.

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Maximum tolerated dose was identified as lenalidomide 25 mg/day given continuously, with the most common grade 3 or worse adverse events being neutropenia, lymphopenia, and thrombocytopenia. Serious adverse events were found to have occurred in 8 patients.


  1. Ogura M, Imaizumi Y, Uike N, et al. Lenalidomide in relapsed adult T-cell leukaemia-lymphoma or peripheral T-cell lymphoma (ATLL-001): a phase 1, multicentre, dose-escalation study [published online ahead of print February 11, 2016]. Lancet Haematol. doi: 10.1016/S2352-3026(15)00284-7.