{"preliminary_commentary":{"by_channel":{"x_thread":5},"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":null,"indication":null,"name":"NCT03677141","nct_id":"NCT03677141","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03677141. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive M-CHOP up to the phase II recommended dose (RP2D).","label":"Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding","type":"EXPERIMENTAL"},{"description":"Participants will receive M-CHP-Pola up to the RP2D.","label":"Phase Ib: M-CHP-Pola Dose-Finding","type":"EXPERIMENTAL"},{"description":"Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP.","label":"Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort","type":"EXPERIMENTAL"},{"description":"Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage.","label":"Phase II: M-CHP-Pola 1L DLBCL","type":"EXPERIMENTAL"},{"description":"Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.","label":"Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL","type":"ACTIVE_COMPARATOR"},{"description":"Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage.\n\nNOTE: No participants were enrolled to this arm.","label":"Phase II: M-CHOP 1L DLBCL","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-10-12","type":"ACTUAL"},"conditions":["B-cell Non-Hodgkin Lymphoma"],"enrollment":{"count":117,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Mosunetuzumab","otherNames":[],"type":"DRUG"},{"name":"Polatuzumab Vedotin","otherNames":[],"type":"DRUG"},{"name":"Rituxumab","otherNames":[],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Vincristine","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Tocilizumab","otherNames":[],"type":"DRUG"}],"last_update":"2024-12-18","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2023-10-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC)","timeFrame":"6-8 weeks after either C6D1 or last dose of study treatment"}],"references":[{"citation":"Westin J, Phillips TJ, Mehta A, Hoffmann MS, Gonzalez-Barca E, Thieblemont C, Bastos-Oreiro M, Greil R, Giebel S, Wei MC, Wang J, Bucher R, Sit J, Penuel E, Purev E, Yee DL, Bergua-Burgues JM. Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a phase 2 study. Blood Adv. 2025 May 27;9(10):2461-2472. doi: 10.1182/bloodadvances.2024014907.","pmid":"39908481","type":"DERIVED"},{"citation":"Olszewski AJ, Phillips TJ, Hoffmann MS, Armand P, Kim TM, Yoon DH, Mehta A, Greil R, Westin J, Lossos IS, Munoz JL, Sit J, Wei MC, Yang A, Chen V, Purev E, Yee DL, Jaeger U. Mosunetuzumab in combination with CHOP in previously untreated DLBCL: safety and efficacy results from a phase 2 study. Blood Adv. 2023 Oct 24;7(20):6055-6065. doi: 10.1182/bloodadvances.2023010840.","pmid":"37581593","type":"DERIVED"}],"start_date":{"date":"2019-03-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma","url":"https://clinicaltrials.gov/study/NCT03677141"},"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/nct03677141"}