{"preliminary_commentary":{"by_channel":{"youtube":6,"podcast":3,"x_thread":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04662255\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["pirtobrutinib"]],"indication":"previously treated BTK inhibitor naïve mantle cell lymphoma","name":"BRUIN-MCL-321","nct_id":"NCT04662255","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=bruin-mcl-321-nct04662255. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"BRUIN-MCL-321","arms":[{"description":"Orally","label":"Arm A (Pirtobrutinib)","type":"EXPERIMENTAL"},{"description":"Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.","label":"Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)","type":"ACTIVE_COMPARATOR"}],"collaborators":["Eli Lilly and Company"],"completion_date":{"date":"2030-06","type":"ESTIMATED"},"conditions":["Lymphoma, Mantle-Cell"],"enrollment":{"count":500,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pirtobrutinib","otherNames":["LOXO-305","LY3527727"],"type":"DRUG"},{"name":"Ibrutinib","otherNames":["Imbruvica"],"type":"DRUG"},{"name":"Acalabrutinib","otherNames":["Calquence"],"type":"DRUG"},{"name":"Zanubrutinib","otherNames":["Brukinsa"],"type":"DRUG"}],"last_update":"2026-09-23","lead_sponsor":"Loxo Oncology, Inc.","official_title":"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)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-11","type":"ESTIMATED"},"primary_outcomes":[{"measure":"To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)","timeFrame":"Up to approximately 24 months"}],"references":[{"citation":"Loubert A, Creel K, Bhandari NR, Hess LM, Ruppert AS, Abada P, Regnault A, Payakachat N. Psychometric analysis of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library. J Patient Rep Outcomes. 2026 Jun 22;10(1):109. doi: 10.1186/s41687-026-01126-w.","pmid":"42329537","type":"DERIVED"},{"citation":"Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15.","pmid":"36377973","type":"DERIVED"}],"start_date":{"date":"2021-04-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)","url":"https://clinicaltrials.gov/study/NCT04662255"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/bruin-mcl-321-nct04662255"}