{"entity":{"id":"nct04075292","kind":"trial","name":"Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia","aka":[],"tldr":"A phase 3 trial of Acalabrutinib, Rituximab and Chlorambucil in chronic lymphocytic leukaemia, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia is a phase 3 interventional study registered as NCT04075292 by AstraZeneca, with 155 participants enrolled, started 2020-01-20 and due to reach its primary completion in 2024-01-03. Interventions recorded: Acalabrutinib, Rituximab and Chlorambucil. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04075292","url":"https://clinicaltrials.gov/study/NCT04075292"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","rituximab","chlorambucil"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04075292","phase":"3","setting":"A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia","sponsor":"AstraZeneca","started":"2020-01-20","startedType":"actual","yearReported":2025,"enrolled":155,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) Assessed by BICR","primary":true,"unit":"months","arms":[{"name":"Acalabrutinib","n":77,"note":"NA indicated that the median, lower and upper limit of 95% CI were not estimable due to insufficient number of participants with events.; Figures from the ClinicalTrials.gov results section (first posted 2025-01-30), not from a publication"},{"name":"Chlorambucil Plus Rituximab","n":78,"value":15.54,"note":"95% CI 11.53 to 17.54"}],"hr":0.08,"ci":[0.03,0.18],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04075292?tab=results"}]},"route":"/trials/nct04075292/","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":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"acalabrutinib","kind":"drug","name":"Acalabrutinib","route":"/drugs/acalabrutinib/"},{"id":"chlorambucil","kind":"drug","name":"Chlorambucil","route":"/drugs/chlorambucil/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}