{"entity":{"id":"captivate","kind":"trial","name":"CAPTIVATE","aka":[],"tldr":"Fifteen months of two pills, then stop: three-quarters of patients had no detectable leukaemia in the blood, and most remained in remission years later.","summary":"Fixed-duration cohort: CR 55% (primary endpoint met), uMRD in blood 77%, 4-year PFS ~79% (2024 update), retreatment with ibrutinib effective at relapse. MRD-guided cohort tested stopping vs continuing in confirmed uMRD (no PFS difference at 3 years). Blood 2022; JCO 2024. Basis (with GLOW) of the EU approval of fixed-duration ibrutinib-venetoclax.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02910583","url":"https://clinicaltrials.gov/study/NCT02910583"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk","bcl2"],"drugs":["ibrutinib","venetoclax"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":["mrd-negative-cr"],"trials":[],"people":["william-wierda"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02910583","phase":"2","setting":"Previously untreated CLL, age ≤70: 3 cycles ibrutinib lead-in then 12 cycles ibrutinib + venetoclax (fixed-duration cohort n=159; MRD-guided cohort n=164)","sponsor":"Pharmacyclics / AbbVie","result":"CR 55%; uMRD 77%; 4-year PFS ~79%.","started":"2016-09-28","startedType":"actual","yearReported":2021,"enrolled":323,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response (fixed-duration cohort)","primary":true,"unit":"%","arms":[{"name":"Ibrutinib + venetoclax","n":159,"value":55}],"source":"https://ashpublications.org/blood/article/139/22/3278/484118"},{"endpoint":"Undetectable MRD in peripheral blood","unit":"%","arms":[{"name":"Ibrutinib + venetoclax","value":77}],"source":"https://doi.org/10.1182/blood.2021014488"}],"replication":"GLOW (randomised, older/unfit) confirmed fixed-duration ibrutinib-venetoclax superiority over chemoimmunotherapy; AMPLIFY replicated the BTKi + venetoclax fixed-duration concept with acalabrutinib."},"route":"/trials/captivate/","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":"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/"}],"drug":[{"id":"ibrutinib","kind":"drug","name":"Ibrutinib","route":"/drugs/ibrutinib/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"}],"term":[{"id":"mrd-negative-cr","kind":"term","name":"MRD-negative complete remission","route":"/terms/mrd-negative-cr/"},{"id":"smart-design","kind":"term","name":"SMART design (sequential multiple assignment randomised trial)","route":"/terms/smart-design/"},{"id":"surrogate-validation","kind":"term","name":"Surrogate endpoint validation: which stand-ins have earned trust","route":"/terms/surrogate-validation/"}],"person":[{"id":"william-wierda","kind":"person","name":"William G. Wierda","route":"/people/william-wierda/"}],"pairing":[{"id":"btki-plus-venetoclax-fixed-duration","kind":"pairing","name":"BTK inhibitor + venetoclax, fixed duration","route":"/pairings/btki-plus-venetoclax-fixed-duration/"}],"idea":[{"id":"idea-mrd-guided-stop-cll","kind":"idea","name":"MRD-guided treatment duration in CLL","route":"/ideas/idea-mrd-guided-stop-cll/"}]}}