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Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): A multicentre, single-arm, phase 2 study

The Lancet Haematology Jul 16, 2019

Morschhauser F, et al. - Among previously treated patients with relapsed or refractory follicular lymphoma from 24 Lymphoma Academic Research Organisation centres in France, researchers investigated the activity and safety of lenalidomide plus obinutuzumab in this multicentre, single-arm, phase 2 study. As induction therapy, oral lenalidomide (20 mg) plus intravenously infused obinutuzumab (1000 mg; six 28-day cycles) was administered to patients, with 1-year maintenance with lenalidomide (10 mg; 12 28-day cycles; days 2–22) plus obinutuzumab (1000 mg; alternate cycles), and 1-year maintenance with obinutuzumab (1000 mg; six 56-day cycles; day 1). At induction end, the overall response was achieved by 68 (79%) of 86 evaluable patients, satisfying the prespecified primary endpoint. For event-free survival, progression-free survival, duration of response, and overall survival, the values at 2 years were 62%, 65%, 70%, and 87%, respectively. Findings revealed the activity of lenalidomide plus obinutuzumab in previously treated patients with relapsed or refractory follicular lymphoma, including those with early relapse. Also, a manageable safety profile was displayed by lenalidomide plus obinutuzumab.
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