{"entity":{"id":"elevate-tn","kind":"trial","name":"ELEVATE-TN","aka":[],"tldr":"Six years on, most patients on acalabrutinib have still not progressed, and adding obinutuzumab also improved survival.","summary":"ELEVATE-TN, trial NCT02475097 sponsored by AstraZeneca and Acerta, published in the Lancet in 2020 with six-year results in Blood in 2025, showed that most previously untreated patients with chronic lymphocytic leukaemia on acalabrutinib have still not progressed six years on, and that adding obinutuzumab also improved survival over chemoimmunotherapy. It randomised 535 patients aged 65 or over or with comorbidities to acalabrutinib with or without obinutuzumab or to chlorambucil plus obinutuzumab, met its primary progression-free survival endpoint with the median not reached in either acalabrutinib arm, and showed a survival advantage for the combination with benefit in high-risk genetic subgroups. Whether obinutuzumab is worth adding for every patient is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02475097","url":"https://clinicaltrials.gov/study/NCT02475097"}],"tags":[],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk","cd20"],"drugs":["acalabrutinib","obinutuzumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["john-byrd"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02475681","phase":"3","setting":"Previously untreated CLL, age ≥65 or with comorbidities: acalabrutinib ± obinutuzumab vs chlorambucil + obinutuzumab","sponsor":"AstraZeneca / Acerta","result":"6-year median PFS not reached vs 27.8 months; OS HR 0.62 (A+O).","started":"2015-06-26","startedType":"actual","yearReported":2019,"enrolled":535,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (median, 6-year follow-up)","primary":true,"unit":"months","arms":[{"name":"Acalabrutinib + obinutuzumab","n":179,"note":"Median not reached"},{"name":"Acalabrutinib","n":179,"note":"Median not reached"},{"name":"Chlorambucil + obinutuzumab","n":177,"value":27.8}],"source":"https://ashpublications.org/blood/article/146/11/1276/536611/Acalabrutinib-obinutuzumab-improves-survival-vs"},{"endpoint":"Overall survival (A+O vs O+Clb)","arms":[{"name":"Acalabrutinib + obinutuzumab"},{"name":"Chlorambucil + obinutuzumab"}],"hr":0.62,"source":"https://doi.org/10.1016/S0140-6736(20)30262-2"}],"replication":"SEQUOIA (zanubrutinib) and RESONATE-2 (ibrutinib) show the same class effect of continuous BTK inhibition over chemoimmunotherapy in frontline."},"route":"/trials/elevate-tn/","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":"btk","kind":"target","name":"BTK (Bruton tyrosine kinase)","route":"/targets/btk/"},{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"acalabrutinib","kind":"drug","name":"Acalabrutinib","route":"/drugs/acalabrutinib/"},{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"person":[{"id":"john-byrd","kind":"person","name":"John C. Byrd","route":"/people/john-byrd/"}],"paper":[{"id":"paper-elevate-tn-acalabrutinib-lancet-2020","kind":"paper","name":"ELEVATE-TN: acalabrutinib, alone or with obinutuzumab, against chemo-immunotherapy in untreated CLL","route":"/key-papers/paper-elevate-tn-acalabrutinib-lancet-2020/"}]}}