{"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":null,"indication":null,"name":"NCT01796002","nct_id":"NCT01796002","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01796002. 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":"Patients in experimental arm receive romidepsin plus CHOP (Ro-CHOP) administered in 3 week cycles for 6 cycles.\n\nRomidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.","label":"Experimental: Romidepsin plus CHOP","type":"EXPERIMENTAL"},{"description":"Patients in control Arm receive cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.","label":"Standard: CHOP","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-12-13","type":"ACTUAL"},"conditions":["Peripheral T-cell Lymphoma"],"enrollment":{"count":421,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Romidepsin + CHOP","otherNames":[],"type":"DRUG"},{"name":"CHOP","otherNames":[],"type":"DRUG"}],"last_update":"2023-01-10","lead_sponsor":"The Lymphoma Academic Research Organisation","official_title":"Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-12-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"The primary efficacy endpoint is Progression Free Survival","timeFrame":"60 months"}],"references":[{"citation":"Camus V, Thieblemont C, Gaulard P, Cheminant M, Casasnovas RO, Ysebaert L, Damaj GL, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Gutierrez N, Penarrubia MJ, Staber PB, Trotman J, Huttmann A, Stefoni V, Tucci A, Fogarty P, Farhat H, Abraham J, Abarah W, Belmecheri F, Ribrag V, Delfau-Larue MH, Cottereau AS, Itti E, Li J, Delarue R, de Leval L, Morschhauser F, Bachy E. Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial. J Clin Oncol. 2024 May 10;42(14):1612-1618. doi: 10.1200/JCO.23.01687. Epub 2024 Feb 16.","pmid":"38364196","type":"DERIVED"},{"citation":"Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Garcia-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Huttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. doi: 10.1200/JCO.21.01815. Epub 2021 Nov 29.","pmid":"34843406","type":"DERIVED"}],"start_date":{"date":"2013-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma","url":"https://clinicaltrials.gov/study/NCT01796002"},"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/nct01796002"}