{"entity":{"id":"nct02970318","kind":"trial","name":"A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL","aka":[],"tldr":"A phase 3 trial of Acalabrutinib, Rituximab, Idelalisib and Bendamustine in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.","summary":"A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL is a phase 3 interventional study registered as NCT02970318 by Acerta Pharma BV, with 310 participants enrolled, started 2017-02-02 and due to reach its primary completion in 2021-09-03. Interventions recorded: Acalabrutinib (ACP-196), Rituximab, Idelalisib and Bendamustine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02970318","url":"https://clinicaltrials.gov/study/NCT02970318"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","cll-relapsed"],"sections":[],"technologies":["cytotoxic-chemotherapy","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["acalabrutinib","rituximab","idelalisib","bendamustine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02970318","phase":"3","setting":"A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia","sponsor":"Acerta Pharma BV","started":"2017-02-02","startedType":"actual","yearReported":2023,"enrolled":310,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment","primary":true,"unit":"months","arms":[{"name":"Arm A: Acalabrutinib Monotherapy","n":155,"note":"Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-29), not from a publication"},{"name":"Arm B: Investigators Choice","n":155,"value":16.5,"note":"95% CI 14.0 to 17.1"}],"hr":0.31,"ci":[0.2,0.49],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02970318?tab=results"},{"endpoint":"IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis","unit":"participants","arms":[{"name":"Arm A: Acalabrutinib Monotherapy","n":155,"value":126,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-06-29), not from a publication"},{"name":"Arm B: Investigator's Choice","n":155,"value":117}],"p":"0.2248","source":"https://clinicaltrials.gov/study/NCT02970318?tab=results"}]},"route":"/trials/nct02970318/","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":"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":"bendamustine","kind":"drug","name":"Bendamustine","route":"/drugs/bendamustine/"},{"id":"idelalisib","kind":"drug","name":"Idelalisib","route":"/drugs/idelalisib/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}