{"entity":{"id":"cll14","kind":"trial","name":"CLL14","aka":[],"tldr":"One year of two targeted drugs, then nothing: more than half of patients were still progression-free six years later, off all treatment.","summary":"Median PFS 76.2 vs 36.4 months (HR 0.40); 6-year PFS 53.1% vs 21.7%; time to next treatment 65.2% vs 37.1% at 6 years; uMRD at end of treatment 75.5% vs 35.2%; OS difference not statistically significant. NEJM 2019; Blood 2024 (6-year). Established fixed-duration therapy as a CLL standard and uMRD as a predictor of durable remission.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02242942","url":"https://clinicaltrials.gov/study/NCT02242942"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":["bcl2","cd20"],"drugs":["venetoclax","obinutuzumab"],"companies":["german-cll-study-group"],"institutions":[],"pathways":[],"terms":["mrd-negative-cr","tumor-lysis-syndrome"],"trials":[],"people":["kirsten-fischer","michael-hallek"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02242942","phase":"3","setting":"Previously untreated CLL with coexisting conditions: 12 months of venetoclax + obinutuzumab vs chlorambucil + obinutuzumab","sponsor":"German CLL Study Group / Roche / AbbVie","result":"6-year PFS 53.1% vs 21.7%; HR 0.40.","started":"2014-12-31","startedType":"actual","yearReported":2019,"enrolled":445,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Venetoclax + obinutuzumab","n":216,"value":76.2},{"name":"Chlorambucil + obinutuzumab","n":216,"value":36.4}],"hr":0.4,"p":"<0.0001","source":"https://ashpublications.org/blood/article/144/18/1924/516941/Venetoclax-obinutuzumab-for-previously-untreated"},{"endpoint":"Progression-free survival at 6 years","unit":"%","arms":[{"name":"Venetoclax + obinutuzumab","value":53.1},{"name":"Chlorambucil + obinutuzumab","value":21.7}],"source":"https://doi.org/10.1056/NEJMoa1815281"},{"endpoint":"Undetectable MRD in blood at end of treatment","unit":"%","arms":[{"name":"Venetoclax + obinutuzumab","value":75.5},{"name":"Chlorambucil + obinutuzumab","value":35.2}],"source":"https://doi.org/10.1056/NEJMoa1815281"}],"replication":"CLL13/GAIA (fit patients) reproduced venetoclax-obinutuzumab superiority over chemoimmunotherapy; real-world registries confirm ~2-year PFS >85%."},"route":"/trials/cll14/","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":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"},{"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":"mrd-negative-cr","kind":"term","name":"MRD-negative complete remission","route":"/terms/mrd-negative-cr/"},{"id":"tumor-lysis-syndrome","kind":"term","name":"Tumour lysis syndrome (TLS)","route":"/terms/tumor-lysis-syndrome/"}],"person":[{"id":"kirsten-fischer","kind":"person","name":"Kirsten Fischer","route":"/people/kirsten-fischer/"},{"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/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"}],"paper":[{"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/"}]}}