{"entity":{"id":"nct04971226","kind":"trial","name":"A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP","aka":["ASC4FIRST"],"tldr":"A phase 3 trial of Imatinib, Nilotinib, Bosutinib, Dasatinib and Asciminib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP is a phase 3 interventional study registered as NCT04971226 by Novartis Pharmaceuticals, with 405 participants enrolled, started 2021-10-06 and due to reach its primary completion in 2023-11-28. Interventions recorded: Imatinib, Nilotinib, Bosutinib, Dasatinib and Asciminib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04971226","url":"https://clinicaltrials.gov/study/NCT04971226"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["imatinib","nilotinib","bosutinib","dasatinib","asciminib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04971226","phase":"3","setting":"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","sponsor":"Novartis Pharmaceuticals","started":"2021-10-06","startedType":"actual","yearReported":2025,"enrolled":405,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI","primary":true,"unit":"participants","arms":[{"name":"Asciminib (All Asciminib )","n":201,"value":136,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-03-10), not from a publication"},{"name":"Investigator Selected TKI (All Comparators)","n":204,"value":100}],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT04971226?tab=results"}]},"route":"/trials/nct04971226/","neighbours":{"cancer":[{"id":"cml","kind":"cancer","name":"Chronic myeloid leukaemia (CML)","route":"/cancers/cml/"},{"id":"cml-chronic-phase","kind":"cancer","name":"Chronic myeloid leukaemia, chronic phase","route":"/cancers/cml-chronic-phase/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"asciminib","kind":"drug","name":"Asciminib","route":"/drugs/asciminib/"},{"id":"bosutinib","kind":"drug","name":"Bosutinib","route":"/drugs/bosutinib/"},{"id":"dasatinib","kind":"drug","name":"Dasatinib","route":"/drugs/dasatinib/"},{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"},{"id":"nilotinib","kind":"drug","name":"Nilotinib","route":"/drugs/nilotinib/"}],"company":[{"id":"advanced-accelerator-applications","kind":"company","name":"Advanced Accelerator Applications (Novartis)","route":"/companies/advanced-accelerator-applications/"},{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}]}}