{"entity":{"id":"nct02029443","kind":"trial","name":"ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia","aka":[],"tldr":"A phase 1/2 trial of Acalabrutinib in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.","summary":"ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia is a phase 1/2 interventional study registered as NCT02029443 by Acerta Pharma BV, with 306 participants enrolled, started 2014-01-30 and due to reach its primary completion in 2021-07-15. Interventions recorded: Acalabrutinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02029443","url":"https://clinicaltrials.gov/study/NCT02029443"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","richter-transformation-cll"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02029443","phase":"1/2","setting":"A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects With Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia","sponsor":"Acerta Pharma BV","started":"2014-01-30","startedType":"actual","yearReported":2022,"enrolled":306,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1","primary":true,"unit":"participants","arms":[{"name":"Cohort 1","n":9,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2022-09-10), not from a publication"},{"name":"Cohort 2a","n":8,"value":0},{"name":"Cohort 2b","n":29,"value":0},{"name":"Cohort 3","n":7,"value":0},{"name":"Cohort 4a","n":6,"value":0},{"name":"Cohort 4b","n":6,"value":0}],"source":"https://clinicaltrials.gov/study/NCT02029443?tab=results"}]},"route":"/trials/nct02029443/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"richter-transformation-cll","kind":"cancer","name":"Richter transformation of chronic lymphocytic leukaemia","route":"/cancers/richter-transformation-cll/"},{"id":"t-cell-prolymphocytic-leukaemia","kind":"cancer","name":"T-cell prolymphocytic leukaemia","route":"/cancers/t-cell-prolymphocytic-leukaemia/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"acalabrutinib","kind":"drug","name":"Acalabrutinib","route":"/drugs/acalabrutinib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-acalabrutinib-cll-n-engl-j-med-2016","kind":"paper","name":"Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia","route":"/key-papers/paper-acalabrutinib-cll-n-engl-j-med-2016/"}]}}