{"preliminary_commentary":{"by_channel":{"x_thread":35,"youtube":19,"podcast":16,"x_video":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\": \"NCT04971226\", \"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":[["asciminib"]],"indication":"newly diagnosed Ph+ chronic-phase chronic myeloid leukemia","name":"ASC4FIRST","nct_id":"NCT04971226","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=asc4first-nct04971226. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs","label":"Asciminib","type":"EXPERIMENTAL"},{"description":"Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments:\n\nImatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food","label":"Investigator selected TKIs","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2031-01-18","type":"ESTIMATED"},"conditions":["Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive"],"enrollment":{"count":405,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Imatinib","otherNames":["STI571"],"type":"DRUG"},{"name":"Nilotinib","otherNames":["AMN107"],"type":"DRUG"},{"name":"Bosutinib","otherNames":[],"type":"DRUG"},{"name":"Dasatinib","otherNames":[],"type":"DRUG"},{"name":"Asciminib","otherNames":["ABL001"],"type":"DRUG"}],"last_update":"2026-08-28","lead_sponsor":"Novartis Pharmaceuticals","official_title":"A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-11-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI","timeFrame":"At 48 weeks"},{"measure":"Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)","timeFrame":"At 48 weeks"}],"references":[{"citation":"Takahashi N, Kim DW, Kim I, Du X, Lee SE, Hu Y, Kikushige Y, Jiang Q, Wang Y, Chen S, Zhu H, Goto T, Tomita A, Ichii M, Nakamae H, Liu L, Liu B, Malek K, Zhu T, Wu S, Wang J. Asciminib Provides Better Efficacy and Favorable Safety and Tolerability Against Investigator-Selected Tyrosine Kinase Inhibitors in East Asian Patients With Newly Diagnosed Chronic Myeloid Leukemia: Results From a Subgroup Analysis of the Pivotal ASC4FIRST Study. Cancer Med. 2026 Jun;15(6):e72019. doi: 10.1002/cam4.72019.","pmid":"42339511","type":"DERIVED"},{"citation":"Cortes JE, Hughes TP, Wang J, Kim DW, Kim DDH, Mayer J, Goh YT, le Coutre P, Etienne G, Kim I, Andorsky DJ, Bombaci F, Issa GC, Takahashi N, Kapoor S, Jinwal R, Malek K, McCulloch T, Yau L, Larson RA, Hochhaus A. Asciminib demonstrates superior efficacy and safety in newly diagnosed chronic myeloid leukemia in the ASC4FIRST trial. Blood. 2026 Mar 26;147(13):1433-1446. doi: 10.1182/blood.2025029210.","pmid":"41397287","type":"DERIVED"},{"citation":"Hochhaus A, Wang J, Kim DW, Kim DDH, Mayer J, Goh YT, le Coutre P, Takahashi N, Kim I, Etienne G, Andorsky D, Issa GC, Larson RA, Bombaci F, Kapoor S, McCulloch T, Malek K, Yau L, Ifrah S, Hoch M, Cortes JE, Hughes TP; ASC4FIRST Investigators. Asciminib in Newly Diagnosed Chronic Myeloid Leukemia. N Engl J Med. 2024 Sep 12;391(10):885-898. doi: 10.1056/NEJMoa2400858. Epub 2024 May 31.","pmid":"38820078","type":"DERIVED"},{"citation":"Cortes JE, Hochhaus A, Takahashi N, Larson RA, Issa GC, Bombaci F, Ramscar N, Ifrah S, Hughes TP. Asciminib monotherapy for newly diagnosed chronic myeloid leukemia in chronic phase: the ASC4FIRST phase III trial. Future Oncol. 2022 Dec;18(38):4161-4170. doi: 10.2217/fon-2022-0923. Epub 2022 Dec 16.","pmid":"36524980","type":"DERIVED"}],"start_date":{"date":"2021-10-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP","url":"https://clinicaltrials.gov/study/NCT04971226"},"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/asc4first-nct04971226"}