{"entity":{"id":"nct05456191","kind":"trial","name":"A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)","aka":[],"tldr":"A phase 3 trial of Asciminib and Nilotinib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) is a phase 3 interventional study registered as NCT05456191 by Novartis Pharmaceuticals, with 568 participants enrolled, started 2022-11-21 and due to reach its primary completion in 2025-05-15. Interventions recorded: Asciminib and Nilotinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05456191","url":"https://clinicaltrials.gov/study/NCT05456191"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["asciminib","nilotinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05456191","phase":"3","setting":"A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.","sponsor":"Novartis Pharmaceuticals","started":"2022-11-21","startedType":"actual","yearReported":2026,"enrolled":568,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)","primary":true,"unit":"participants","arms":[{"name":"Asciminib","n":284,"value":16,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-05-27), not from a publication"},{"name":"Nilotinib","n":282,"value":34}],"hr":0.45,"ci":[0.25,0.81],"p":"0.004","source":"https://clinicaltrials.gov/study/NCT05456191?tab=results"}]},"route":"/trials/nct05456191/","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":"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/"}]}}