{"commentary":{"count":88,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":38,"podcast":25,"x_thread":25},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03112174\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"SYMPATICO","nct_id":"NCT03112174","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=sympatico-nct03112174. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"SYMPATICO","arms":[{"description":"Participants with a low or high risk of TLS enroll into the open-label Safety Run-in Period to receive concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramp up to a target dose of 400 mg once daily over a 5-week period.","label":"Safety Run-in","type":"EXPERIMENTAL"},{"description":"Participants randomized to ibrutinib and venetoclax for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax is discontinued after 104 weeks of treatment, regardless of response assessment.","label":"Randomization Phase: Ibrutinb + Venetoclax","type":"EXPERIMENTAL"},{"description":"Participants randomized to ibrutinib and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo is discontinued after 104 weeks of treatment, regardless of response assessment.","label":"Randomization Phase: Ibrutinib + Placebo","type":"PLACEBO_COMPARATOR"},{"description":"Participants are treated with ibrutinib 560 mg and venetoclax 400 mg, administered using the 5-week ramp-up schedule.","label":"Treatment-naive Open-label Arm","type":"EXPERIMENTAL"}],"collaborators":["Janssen Research & Development, LLC"],"completion_date":{"date":"2024-06-27","type":"ACTUAL"},"conditions":["Mantle-Cell Lymphoma"],"enrollment":{"count":366,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ibrutinib","type":"DRUG"},{"name":"Venetoclax","type":"DRUG"},{"name":"Placebo Oral tablet to match Venetoclax","type":"DRUG"}],"last_update":"2025-07-22","lead_sponsor":"Pharmacyclics LLC.","official_title":"Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-06-26","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in)","timeFrame":"After at least 3 months of treatment, with an overall median treatment duration of 20.0 months"},{"measure":"Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)","timeFrame":"After at least 3 months of treatment, with an overall median treatment duration of 20.0 months"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in)","timeFrame":"From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 20.0 months"},{"measure":"Progression-free Survival (PFS) (Randomization Phase)","timeFrame":"For an overall median time on study of 61.34 months"},{"measure":"Complete Response (CR) Rate (Treatment-Naive Arm)","timeFrame":"For an overall median time on study of 40.51 months"}],"references":[{"citation":"Wang M, Hoffmann MS, Wrobel T, Trneny M, Belada D, Demirken F, Panayiotidis P, Jurczak W, Zinzani PL, Keating MM, Yoon SS, Egyed M, Tam CS, Johnson NA, Szafer Glusman E, Lin J, Dean JP, Neuenburg JK, von Keudell G. First-line ibrutinib plus venetoclax for non-blastoid mantle cell lymphoma in patients >/=65 years or with TP53 mutations. Blood. 2026 Jul 1:blood.2025032833. doi: 10.1182/blood.2025032833. Online ahead of print.","pmid":"42462092","type":"DERIVED"},{"citation":"Wang M, Jurczak W, Trneny M, Belada D, Wrobel T, Ghosh N, Keating MM, van Meerten T, Alvarez RF, von Keudell G, Thieblemont C, Peyrade F, Andre M, Hoffmann M, Szafer-Glusman E, Lin J, Dean JP, Neuenburg JK, Tam CS. Ibrutinib plus venetoclax in relapsed or refractory mantle cell lymphoma (SYMPATICO): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2025 Feb;26(2):200-213. doi: 10.1016/S1470-2045(24)00682-X.","pmid":"39914418","type":"DERIVED"},{"citation":"Wang M, Ramchandren R, Chen R, Karlin L, Chong G, Jurczak W, Wu KL, Bishton M, Collins GP, Eliadis P, Peyrade F, Lee Y, Eckert K, Neuenburg JK, Tam CS. Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study. J Hematol Oncol. 2021 Oct 30;14(1):179. doi: 10.1186/s13045-021-01188-x.","pmid":"34717692","type":"DERIVED"}],"start_date":{"date":"2017-06-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)","url":"https://clinicaltrials.gov/study/NCT03112174"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/sympatico-nct03112174"}