Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm 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) (ASC4START)

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

Conditions Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Interventions Asciminib Nilotinib

Updated 30 times since 2022 Last updated: Feb 4, 2026 Started: Nov 21, 2022 Primary completion: May 15, 2025 Completion: Jul 7, 2031

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Philadelphia Chromosome-Positive Chronic Myeloid Leukemia, this trial is ongoing. The trial is conducted by Novartis Pharmaceuticals and has accumulated 30 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

30 versions recorded

Feb 2026 — Present [monthly]

Active Not Recruiting PHASE3
Nov 2025 — Feb 2026 [monthly]

Active Not Recruiting PHASE3
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Active Not Recruiting PHASE3

▶ Show 25 earlier versions

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Status: Recruiting → Active Not Recruiting
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Recruiting PHASE3
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Recruiting PHASE3
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Recruiting PHASE3
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Dec 2022 — Jan 2023 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Sep 2022 — Dec 2022 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aachen, Germany , Abu Dhabi, United Arab Emirates , Ahmedabad, India , Alor Star, Malaysia , Amman, Jordan , Ankara, Turkey (Türkiye) , Asheville, United States , Athens, Greece , Augsburg, Germany , Bad Saarow, Germany and 98 more locations