{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T16:48:55Z","timestamp":1781801335676,"version":"3.54.5"},"reference-count":27,"publisher":"American Society of Hematology","issue":"15","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,4,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Obinutuzumab and lenalidomide (referred to as the GALEN combination) is an active immunomodulatory combination with a manageable safety profile in multiple types of lymphoma. We report efficacy and safety results for the phase 2 GALEN study in previously untreated patients with advanced follicular lymphoma (FL). Eligible patients aged \u226518 years had an Eastern Cooperative Oncology Group performance status \u22642 and high-tumor burden, grade 1 to 3a FL. Induction treatment was obinutuzumab (1000 mg IV, days 8, 15, and 22, cycle 1; day 1, cycles 2-6) plus lenalidomide (20 mg\/d, days 1-21, cycle 1; days 2-22, cycles 2-6) for six 28-day cycles. Maintenance included obinutuzumab (1000 mg every 2 cycles) plus lenalidomide (10 mg, days 2-22) for \u226412 cycles (year 1) followed by obinutuzumab (1000 mg every 56 days) for 6 cycles (year 2). The primary end point was complete response rate (CRR) after induction per the 1999 International Working Group criteria. From October 2015 to February 2017, a total of 100 patients were enrolled. CRR after induction was 47%, and the overall response rate (ORR) was 92%. Post hoc analyses per the 2014 Lugano classification, including patients with missing bone marrow assessments, identified an additional 13 patients fulfilling CRR criteria, resulting in a complete metabolic response of 80% and an ORR of 94%. At a median follow-up of 3.7 years, 3-year progression-free survival and overall survival were 82% and 94%, respectively. The most common adverse event was neutropenia (48% any grade; 47% grade \u22653). Only 2% of patients presented with febrile neutropenia; others were mainly grade \u22642. No other specific grade \u22653 toxicity occurred at a frequency &amp;gt;3%. Overall, these results showed promising clinical efficacy for the chemotherapy-free GALEN backbone in previously untreated patients with high tumor burden FL. Except for neutropenia, the safety profile of the combination is remarkable. The study was registered at clinicaltrials.gov as #NCT01582776.<\/jats:p>","DOI":"10.1182\/blood.2021013526","type":"journal-article","created":{"date-parts":[[2021,12,22]],"date-time":"2021-12-22T19:54:19Z","timestamp":1640202859000},"page":"2338-2346","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":34,"title":["Obinutuzumab plus lenalidomide in advanced, previously untreated follicular lymphoma in need of systemic therapy: a LYSA study"],"prefix":"10.1182","volume":"139","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2694-7510","authenticated-orcid":false,"given":"Emmanuel","family":"Bachy","sequence":"first","affiliation":[{"name":"Hematology Department, Hospices Civils de Lyon, Lyon 1 Claude Bernard University, Lyon, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roch","family":"Houot","sequence":"additional","affiliation":[{"name":"Hematology Department, CHU Rennes, Rennes, 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