{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"drugs_tested":[["ibrutinib"]],"indication":"newly diagnosed mantle cell lymphoma","name":"NCT01776840","nct_id":"NCT01776840","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01776840. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":null,"label":"Treatment Arm A","type":"PLACEBO_COMPARATOR"},{"description":null,"label":"Treatment Arm B","type":"EXPERIMENTAL"}],"collaborators":["Pharmacyclics LLC."],"completion_date":{"date":"2024-06-24","type":"ACTUAL"},"conditions":["Mantle Cell Lymphoma"],"enrollment":{"count":523,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Bendamustine","otherNames":[],"type":"DRUG"},{"name":"Rituximab","otherNames":[],"type":"DRUG"},{"name":"Ibrutinib","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2025-07-08","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-06-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"Up to 97 months"}],"references":[{"citation":"Wang ML, Jurczak W, Jerkeman M, Trotman J, Zinzani PL, Belada D, Boccomini C, Flinn IW, Giri P, Goy A, Hamlin PA, Hermine O, Hernandez-Rivas JA, Hong X, Kim SJ, Lewis D, Mishima Y, Ozcan M, Perini GF, Pocock C, Song Y, Spurgeon SE, Storring JM, Walewski J, Zhu J, Qin R, Henninger T, Deshpande S, Howes A, Le Gouill S, Dreyling M; SHINE Investigators. Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma. N Engl J Med. 2022 Jun 30;386(26):2482-2494. doi: 10.1056/NEJMoa2201817. Epub 2022 Jun 3.","pmid":"35657079","type":"DERIVED"}],"start_date":{"date":"2013-05-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma","url":"https://clinicaltrials.gov/study/NCT01776840"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct01776840"}