# 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)

Source: https://onco.cc/trials/nct05456191/  
OnCo record `nct05456191` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: 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
- Enrolled: 568
- Outcomes: Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis): Asciminib 16 participants vs Nilotinib 34 participants, HR 0.45

## Sources

- ClinicalTrials.gov NCT05456191: https://clinicaltrials.gov/study/NCT05456191

## Connected records

- cancers: [Chronic myeloid leukaemia (CML)](https://onco.cc/cancers/cml/), [Chronic myeloid leukaemia, chronic phase](https://onco.cc/cancers/cml-chronic-phase/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Asciminib](https://onco.cc/drugs/asciminib/), [Nilotinib](https://onco.cc/drugs/nilotinib/)
- companies: [Advanced Accelerator Applications (Novartis)](https://onco.cc/companies/advanced-accelerator-applications/), [Novartis](https://onco.cc/companies/novartis/)

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