{"preliminary_commentary":{"by_channel":{"x_thread":15,"podcast":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\": \"NCT00118209\", \"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":[["DA-EPOCH-R"]],"indication":"untreated diffuse large B-cell lymphoma","name":"CALGB 50303","nct_id":"NCT00118209","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=calgb-50303-nct00118209. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive the following treatment:\n\n* Rituximab 375 mg/m\\^2 IV infusion on Day 1 prior to CHOP chemotherapy\n* Cyclophosphamide 750 mg/m\\^2 IV on Day 1\n* Doxorubicin 50 mg/m\\^2 IV on Day 1\n* Vincristine 1.4 mg/m\\^2 IV (2 mg cap) on Day 1\n* Prednisone 40 mg/m\\^2/day PO on Days 1-5\n* filgrastim or pegfilgrastim as defined in the protocol\n\nRequired ancillary medications is administered during all cycles as defined in the protocol.\n\nCycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.","label":"Arm A - R-CHOP","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive the following treatment:\n\nCycle 1 Doses:\n\n* Rituximab 375 mg/m\\^2 IV infusion on Day 1 prior to EPOCH chemotherapy\n* Doxorubicin 10 mg/m\\^2/day CIVI on Days 1-4\n* Etoposide 50 mg/m\\^2/day CIVI on Days 1-4\n* Vincristine 0.4 mg/m\\^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours)\n* Cyclophosphamide 750 mg/m\\^2 IV on Day 5 (following completion of 96 hour infusions)\n* Prednisone 60 mg/m\\^2 PO BID on Days 1-5\n* Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC \\> 5000 after the nadir (nadir usually between Days 10-12) or for 10 days (Days 6-15) if the ANC is not being monitored, during every cycle.\n\nDoses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle.\n\nRequired ancillary medications are administered during all cycles as defined in the protocol.\n\nCycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.","label":"Arm B - DA-EPOCH-R","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2021-11-15","type":"ACTUAL"},"conditions":["Large B Cell Lymphoma"],"enrollment":{"count":524,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"rituximab","otherNames":[],"type":"BIOLOGICAL"},{"name":"cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"doxorubicin","otherNames":[],"type":"DRUG"},{"name":"vincristine","otherNames":[],"type":"DRUG"},{"name":"prednisone","otherNames":[],"type":"DRUG"},{"name":"etoposide","otherNames":[],"type":"DRUG"},{"name":"filgrastim","otherNames":[],"type":"DRUG"},{"name":"pegfilgrastim","otherNames":[],"type":"DRUG"}],"last_update":"2021-11-17","lead_sponsor":"Alliance for Clinical Trials in Oncology","official_title":"Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2017-10","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival Rate at 2 and 5 Years","timeFrame":"Up to 5 years post-registration"}],"references":[{"citation":"Morrison VA, Le-Rademacher J, Bobek O, Satele D, Leonard JP, Jatoi A. Association of age and performance status with adverse events in older adults with diffuse large B-cell lymphoma receiving frontline R-CHOP therapy: Alliance 151930, a secondary analysis of the phase III trial CALGB 50303. J Geriatr Oncol. 2025 Mar;16(2):102185. doi: 10.1016/j.jgo.2025.102185. Epub 2025 Jan 13.","pmid":"39809075","type":"DERIVED"},{"citation":"Schoder H, Polley MC, Knopp MV, Hall N, Kostakoglu L, Zhang J, Higley HR, Kelloff G, Liu H, Zelenetz AD, Cheson BD, Wagner-Johnston N, Kahl BS, Friedberg JW, Hsi ED, Leonard JP, Schwartz LH, Wilson WH, Bartlett NL. Prognostic value of interim FDG-PET in diffuse large cell lymphoma: results from the CALGB 50303 Clinical Trial. Blood. 2020 Jun 18;135(25):2224-2234. doi: 10.1182/blood.2019003277.","pmid":"32232481","type":"DERIVED"},{"citation":"Bartlett NL, Wilson WH, Jung SH, Hsi ED, Maurer MJ, Pederson LD, Polley MC, Pitcher BN, Cheson BD, Kahl BS, Friedberg JW, Staudt LM, Wagner-Johnston ND, Blum KA, Abramson JS, Reddy NM, Winter JN, Chang JE, Gopal AK, Chadburn A, Mathew S, Fisher RI, Richards KL, Schoder H, Zelenetz AD, Leonard JP. Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol. 2019 Jul 20;37(21):1790-1799. doi: 10.1200/JCO.18.01994. Epub 2019 Apr 2.","pmid":"30939090","type":"DERIVED"},{"citation":"Barta SK, Lee JY, Kaplan LD, Noy A, Sparano JA. Pooled analysis of AIDS malignancy consortium trials evaluating rituximab plus CHOP or infusional EPOCH chemotherapy in HIV-associated non-Hodgkin lymphoma. Cancer. 2012 Aug 15;118(16):3977-83. doi: 10.1002/cncr.26723. Epub 2011 Dec 16.","pmid":"22180164","type":"DERIVED"}],"start_date":{"date":"2005-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma","url":"https://clinicaltrials.gov/study/NCT00118209"},"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/calgb-50303-nct00118209"}