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

Publication date: Available online 8 July 2019Source: The Lancet HaematologyAuthor(s): Franck Morschhauser, Steven Le Gouill, Pierre Feugier, Sarah Bailly, Emmanuelle Nicolas-Virelizier, Fontanet Bijou, Gilles A Salles, Hervé Tilly, Christophe Fruchart, Koen Van Eygen, Sylvia Snauwaert, Christophe Bonnet, Corinne Haioun, Catherine Thieblemont, Reda Bouabdallah, Ka Lung Wu, Danielle Canioni, Véronique Meignin, Guillaume Cartron, Roch HouotSummaryBackgroundLenalidomide plus rituximab is approved to treat patients with relapsed or refractory follicular lymphoma. Obinutuzumab has been shown to enhance antibody-dependent cellular cytotoxicity, phagocytosis, and direct B-cell killing better than rituximab. Our aim was to determine the activity and safety of lenalidomide plus obinutuzumab in previously treated patients with relapsed or refractory follicular lymphoma.MethodsIn this multicentre, single-arm, phase 2 study, patients were enrolled from 24 Lymphoma Academic Research Organisation centres in France. Eligible patients (age ≥18 years) had histologically confirmed CD20-positive relapsed or refractory follicular lymphoma of WHO grade 1, 2, or 3a; an ECOG performance status of 0–2; and received at least one previous rituximab-containing therapy. Patients received oral lenalidomide (20 mg) plus intravenously infused obinutuzumab as induction therapy (1000 mg; six 28-day cycles), 1-year maintenance with lenalidomide (10 mg; 12 28-day cycles; days 2–22) plus obinutuzumab (1...

Source: The Lancet Haematology - July 10, 2019 Category: Hematology Source Type: research