{"entity":{"id":"cll13-gaia","kind":"trial","name":"CLL13 / GAIA","aka":[],"tldr":"In fit patients, one year of venetoclax plus obinutuzumab (with or without ibrutinib) clearly beat the old chemotherapy standard.","summary":"Co-primary endpoints: uMRD at month 15 (GIV 92.2%, GV 86.5%, RV 57.0%, CIT 52.0%) and PFS (GIV and GV superior to CIT; RV not). 5-year PFS: GIV 81.3%, GV 69.8%, RV 57.4%, CIT 50.7%; 5-year OS 91-95% in all arms. NEJM 2023; 5-year update 2025-26. Showed that venetoclax needs obinutuzumab rather than rituximab, and that adding ibrutinib improves PFS at the cost of more toxicity.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02950051","url":"https://clinicaltrials.gov/study/NCT02950051"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":["bcl2","cd20","btk"],"drugs":["venetoclax","obinutuzumab","rituximab","ibrutinib"],"companies":["german-cll-study-group"],"institutions":[],"pathways":[],"terms":["ighv-status","mrd-negative-cr"],"trials":[],"people":["barbara-eichhorst","michael-hallek"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02950051","phase":"3","setting":"Fit, previously untreated CLL without del(17p)/TP53: chemoimmunotherapy (FCR/BR) vs venetoclax-rituximab vs venetoclax-obinutuzumab vs venetoclax-obinutuzumab-ibrutinib","sponsor":"German CLL Study Group","result":"5-year PFS 81.3% (GIV), 69.8% (GV), 57.4% (RV), 50.7% (CIT).","started":"2016-12-13","startedType":"actual","yearReported":2023,"enrolled":926,"enrolledBasis":"registry","outcomes":[{"endpoint":"Undetectable MRD at month 15 (blood)","primary":true,"unit":"%","arms":[{"name":"GIV","value":92.2},{"name":"GV","value":86.5},{"name":"RV","value":57},{"name":"Chemoimmunotherapy","value":52}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2213093"},{"endpoint":"Progression-free survival at 5 years","unit":"%","arms":[{"name":"GIV","value":81.3},{"name":"GV","value":69.8},{"name":"RV","value":57.4},{"name":"Chemoimmunotherapy","value":50.7}],"source":"https://doi.org/10.1056/NEJMoa2213093"}],"replication":"Consistent with CLL14 (unfit) and with AMPLIFY (acalabrutinib-venetoclax ± obinutuzumab), which also showed the triplet with obinutuzumab gives the highest PFS."},"route":"/trials/cll13-gaia/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-treatment-naive","kind":"cancer","name":"Chronic lymphocytic leukaemia, first treatment","route":"/cancers/cll-treatment-naive/"}],"technology":[{"id":"bcl2-inhibitors","kind":"technology","name":"BCL-2 inhibitors","route":"/technologies/bcl2-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"bcl2","kind":"target","name":"BCL-2","route":"/targets/bcl2/"},{"id":"btk","kind":"target","name":"BTK (Bruton tyrosine kinase)","route":"/targets/btk/"},{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"ibrutinib","kind":"drug","name":"Ibrutinib","route":"/drugs/ibrutinib/"},{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"company":[{"id":"german-cll-study-group","kind":"company","name":"German CLL Study Group","route":"/companies/german-cll-study-group/"}],"term":[{"id":"ighv-status","kind":"term","name":"IGHV mutational status","route":"/terms/ighv-status/"},{"id":"mrd-negative-cr","kind":"term","name":"MRD-negative complete remission","route":"/terms/mrd-negative-cr/"}],"person":[{"id":"barbara-eichhorst","kind":"person","name":"Barbara Eichhorst","route":"/people/barbara-eichhorst/"},{"id":"michael-hallek","kind":"person","name":"Michael Hallek","route":"/people/michael-hallek/"}],"pairing":[{"id":"venetoclax-plus-obinutuzumab","kind":"pairing","name":"Venetoclax + obinutuzumab (12 months)","route":"/pairings/venetoclax-plus-obinutuzumab/"}],"paper":[{"id":"paper-amplify-acalabrutinib-venetoclax-nejm-2025","kind":"paper","name":"AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients","route":"/key-papers/paper-amplify-acalabrutinib-venetoclax-nejm-2025/"},{"id":"paper-cll14-venetoclax-obinutuzumab-nejm-2019","kind":"paper","name":"CLL14: one year of venetoclax plus obinutuzumab instead of chemo-immunotherapy in older, less fit CLL patients","route":"/key-papers/paper-cll14-venetoclax-obinutuzumab-nejm-2019/"}]}}