{"entity":{"id":"nct04662255","kind":"trial","name":"Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)","aka":["BRUIN MCL-321"],"tldr":"A phase 3 trial of Pirtobrutinib, Ibrutinib, Acalabrutinib and Zanubrutinib in mantle cell lymphoma, run by Loxo Oncology, Inc., active and no longer recruiting.","summary":"Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) is a phase 3 interventional study registered as NCT04662255 by Loxo Oncology, Inc., with 500 participants enrolled, started 2021-04-08 and due to reach its primary completion in 2027-01. Interventions recorded: Pirtobrutinib, Ibrutinib, Acalabrutinib and Zanubrutinib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04662255","url":"https://clinicaltrials.gov/study/NCT04662255"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":["pirtobrutinib","ibrutinib","acalabrutinib","zanubrutinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04662255","phase":"3","setting":"A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)","sponsor":"Loxo Oncology, Inc.","participation":[{"nct":"NCT04662255","source":"https://clinicaltrials.gov/study/NCT04662255","fetchedAt":"2026-10-07T16:53:24.647Z","studySha256":"d8207f4cdcbd42272fea5ad1469c14caa87a6e33bf97c40bafd52303040488cb","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-09-23","leadSponsor":"Loxo Oncology, Inc.","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":500,"enrolmentType":"ESTIMATED","siteCount":189,"recruitingSiteCount":0,"countries":["Australia","Austria","Belgium","Brazil","Canada","China","Czechia","Denmark","France","Germany","Israel","Italy","Japan","Netherlands","New Zealand","Poland","Portugal","Russia","South Korea","Spain","Switzerland","Taiwan","United Kingdom","United States"]}],"started":"2021-04-08","startedType":"actual","enrolled":500,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04662255/","neighbours":{"cancer":[{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"}],"drug":[{"id":"acalabrutinib","kind":"drug","name":"Acalabrutinib","route":"/drugs/acalabrutinib/"},{"id":"ibrutinib","kind":"drug","name":"Ibrutinib","route":"/drugs/ibrutinib/"},{"id":"pirtobrutinib","kind":"drug","name":"Pirtobrutinib","route":"/drugs/pirtobrutinib/"},{"id":"zanubrutinib","kind":"drug","name":"Zanubrutinib","route":"/drugs/zanubrutinib/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}]}}