# 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)

> **NCT05456191** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 568 (actual)

## Conditions studied

- Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

## Interventions

- **DRUG:** Asciminib
- **DRUG:** Nilotinib

## Key facts

- **NCT ID:** NCT05456191
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-11-21
- **Primary completion:** 2025-05-15
- **Final completion:** 2031-07-07
- **Target enrollment:** 568 (ACTUAL)
- **Last updated:** 2026-02-06


## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05456191, "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)". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT05456191. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*