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)
Public ClinicalTrials.gov record NCT05456191. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with newly diagnosed Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
Study identification
- NCT ID
- NCT05456191
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 568 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2022
- Primary completion
- May 14, 2025
- Completion
- Jul 6, 2031
- Last update posted
- Aug 25, 2026
2022 – 2031
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Illinois Cancer Care | Peoria | Illinois | 61615 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| Messino Cancer Centers | Asheville | North Carolina | 28806 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| Williamette Cancer Center | Eugene | Oregon | 97401 | — |
| Texas Oncology P A | Bedford | Texas | 76022 | — |
| Texas Oncology PA Bedford | Bedford | Texas | 76022 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 110 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05456191, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05456191 live on ClinicalTrials.gov.