A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Public ClinicalTrials.gov record NCT04971226. 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 III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI 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 study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD. This study has three periods: 1. Treatment period for all randomized participants, 2. Optional Treatment-Free Remission (TFR) period only for participants meeting TFR eligibility criteria and 3. Treatment Re-Initiation (TRI) period only for participants who relapsed after TFR attempt.
Study identification
- NCT ID
- NCT04971226
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 405 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
- Oct 6, 2021 (Actual)
- Primary completion
- Nov 28, 2023 (Actual)
- Completion
- Jan 18, 2031 (Estimated)
- Last update posted
- Aug 28, 2026
2021 – 2031
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists Pan | Tallahassee | Florida | 32308 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Uni of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Williamette Cancer Center | Eugene | Oregon | 97401 | — |
| Oregon Health Sciences University | Portland | Oregon | 97239 | — |
| Avera Cancer | Sioux Falls | South Dakota | 57105 | — |
| Chattanooga Onc And Hem Assoc PC | Chattanooga | Tennessee | 37404 | — |
| Texas Oncology | Amarillo | Texas | 79124 | — |
| Texas Oncology-Baylor USO | Dallas | Texas | 75246 | — |
| Texas Oncology | Dallas | Texas | 75251 | — |
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 97 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04971226, 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 28, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04971226 live on ClinicalTrials.gov.