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Although chemoimmunotherapy is effective, toxicity remains problematic, and novel treatments are required. We performed a Phase Ib\/II study of obinutuzumab, lenalidomide, and venetoclax in patients with treatment\u2010na\u00efve, high tumor burden, advanced\u2010stage FL. During induction (6\u2009\u00d7\u200928\u2010day cycles), patients received obinutuzumab and venetoclax (in four dose levels from 400\u2009mg day [D]1\u201310 to 800\u2009mg daily) from Cycles 1 to 6 and lenalidomide (20\u2009mg Days 1\u201321) from Cycles 2 to 6. Patients with complete response (CR) received 2 years maintenance obinutuzumab, while partial responders received 2 years obinutuzumab plus 6 months of venetoclax and lenalidomide. Genomic characterization and measurable residual disease (MRD) monitoring were performed using targeted next\u2010generation sequencing (NGS) by circulating tumor DNA (ctDNA). Fifty patients were enrolled with a median age 60. No maximum tolerated dose was defined, and the Phase II dose of venetoclax was 800\u2009mg daily. The CR rate and objective response rate were 86% and 92%, respectively. At median follow\u2010up of 18.3 months, the 2\u2010year progression\u2010free survival and overall survival rates were 92% and 100%, respectively. The most common any\u2010grade adverse events were neutropenia (72%), diarrhea (52%), and upper respiratory infection (48%). Undetectable MRD after one cycle of therapy had a 95% negative predictive value for relapse, while detectable MRD after three cycles of therapy had a 75% positive predictive value. Obinutuzumab, lenalidomide, and venetoclax are active in patients with treatment\u2010na\u00efve high tumor burden FL; however, myelosuppression impacted deliverability. ctDNA MRD is a promising biomarker in FL.<\/jats:p>","DOI":"10.1002\/hem3.70386","type":"journal-article","created":{"date-parts":[[2026,6,7]],"date-time":"2026-06-07T09:25:42Z","timestamp":1780824342000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Obinutuzumab, lenalidomide, and venetoclax for the initial treatment of patients with advanced\u2010stage follicular lymphoma: Results of the Phase Ib\/II LEVERAGE study"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7988-1565","authenticated-orcid":false,"given":"Chan Y.","family":"Cheah","sequence":"first","affiliation":[{"name":"Department of Haematology Sir Charles Gairdner Hospital Perth Australia"},{"name":"Medical School University of Western Australia Perth Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9902-0022","authenticated-orcid":false,"given":"Piers","family":"Blombery","sequence":"additional","affiliation":[{"name":"Department of Haematology Peter MacCallum Cancer Centre and the Royal Melbourne Hospital Melbourne Australia"},{"name":"Sir Peter MacCallum Department of Oncology University of Melbourne Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Johnston","sequence":"additional","affiliation":[{"name":"Department of Haematology Westmead Hospital Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Wight","sequence":"additional","affiliation":[{"name":"Department of Haematology Townsville University Hospital Townsville Australia"},{"name":"School of Medicine James Cook University Townsville Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharine L.","family":"Lewis","sequence":"additional","affiliation":[{"name":"Department of Haematology Sir Charles Gairdner Hospital Perth Australia"},{"name":"Medical School University of Western Australia Perth Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rory","family":"Bennett","sequence":"additional","affiliation":[{"name":"Department of Haematology Peter MacCallum Cancer Centre and the Royal Melbourne Hospital Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Xie","sequence":"additional","affiliation":[{"name":"Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre Melbourne Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stella","family":"Vlachos","sequence":"additional","affiliation":[{"name":"Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre 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MacCallum Department of Oncology University of Melbourne Melbourne 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