{"entity":{"id":"resonate","kind":"trial","name":"RESONATE","aka":[],"tldr":"The trial that made a daily pill the standard for relapsed CLL, cutting the risk of progression by nearly 80%.","summary":"RESONATE, trial NCT01578707 sponsored by Pharmacyclics and Janssen and published in the New England Journal of Medicine in 2014, is the trial that made a daily tablet the standard for relapsed chronic lymphocytic leukaemia, cutting the risk of progression by nearly eighty percent. It randomised 391 patients with relapsed or refractory CLL to ibrutinib or ofatumumab, met its primary progression-free survival endpoint at the interim analysis with a survival benefit as well, and the six-year follow-up showed the advantage maintained including in del(17p) and unmutated IGHV disease, the basis of the 2014 CLL approval. OnCo links it to chronic lymphocytic leukaemia, BTK as a target, ibrutinib, John C. Byrd and The Ohio State University cancer centre. Whether continuous therapy or fixed-duration combinations serve patients better is the question the field has moved on to.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01578707","url":"https://clinicaltrials.gov/study/NCT01578707"}],"tags":[],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk"],"drugs":["ibrutinib","ofatumumab"],"companies":["abbvie","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["john-byrd"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01578707","phase":"3","setting":"Relapsed or refractory CLL/SLL: ibrutinib vs ofatumumab","sponsor":"Pharmacyclics / Janssen","result":"PFS HR 0.22; median PFS 44.1 vs 8.1 months (6-year).","started":"2012-06","startedType":"actual","yearReported":2014,"enrolled":391,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"arms":[{"name":"Ibrutinib","n":195},{"name":"Ofatumumab","n":196}],"hr":0.22,"ci":[0.15,0.32],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1400376"},{"endpoint":"Progression-free survival (median, 6-year follow-up)","unit":"months","arms":[{"name":"Ibrutinib","value":44.1},{"name":"Ofatumumab","value":8.1}],"source":"https://doi.org/10.1056/NEJMoa1400376"}],"replication":"RESONATE-2 (frontline vs chlorambucil), HELIOS, and the Alliance A041202 trial all confirmed BTK-inhibitor superiority over chemoimmunotherapy in CLL."},"route":"/trials/resonate/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-relapsed","kind":"cancer","name":"Relapsed or refractory chronic lymphocytic leukaemia","route":"/cancers/cll-relapsed/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"btk","kind":"target","name":"BTK (Bruton tyrosine kinase)","route":"/targets/btk/"}],"drug":[{"id":"ibrutinib","kind":"drug","name":"Ibrutinib","route":"/drugs/ibrutinib/"},{"id":"ofatumumab","kind":"drug","name":"Ofatumumab","route":"/drugs/ofatumumab/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"},{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"person":[{"id":"john-byrd","kind":"person","name":"John C. Byrd","route":"/people/john-byrd/"}],"institution":[{"id":"osu-james","kind":"institution","name":"The Ohio State University Comprehensive Cancer Center, James Cancer Hospital and Solove Research Institute","route":"/institutions/osu-james/"}]}}