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NCT04971226 · ClinicalTrials.gov registry record · Phase 3
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
A Phase 3 study of Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
- 20
- Study locations
NCT04971226: Active Phase 3 study of Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, sponsored by Novartis Pharmaceuticals.
NCT04971226 is a Phase 3 study of Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 406 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04971226, a Phase 3 study of Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Conditions Studied
Interventions
- DRUG Dasatinib
- DRUG Bosutinib
- DRUG Nilotinib
- DRUG Imatinib
- DRUG Asciminib
Study Locations (20)
Texas
- Texas Oncology-Baylor USO - Dallas
- Texas Oncology - Dallas
- Texas Oncology - Dallas
Florida
- Florida Cancer Specialists - Fort Myers
- Florida Cancer Specialists Pan - Tallahassee
Oregon
- Williamette Cancer Center - Eugene
- Oregon Health Sciences University - Portland
New South Wales
- Novartis Investigative Site - Kingswood
- Novartis Investigative Site - Port Macquarie
Other
- Novartis Investigative Site - Southport
- Novartis Investigative Site - Brussels
Colorado
- Rocky Mountain Cancer Centers - Denver
Kentucky
- University of Kentucky - Lexington
Massachusetts
- Uni of Massachusetts Medical Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2021-10-06 |
| Est. Completion | 2031-01-18 |
| Phase | Phase 3 |
What the registry record for NCT04971226 still lists
NCT04971226 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive appearing as the primary indexed condition, and to 5 interventions - of which Dasatinib is the first listed.
NCT04971226 names 20 study sites across 14 states, led by Texas, Florida, Oregon.
Frequently Asked Questions
What is clinical trial NCT04971226 about?
NCT04971226 is a clinical study titled "A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP". 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...
What is the current status of trial NCT04971226?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2021-10-06. Estimated completion is 2031-01-18.
What conditions does trial NCT04971226 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive.
What interventions are being tested in trial NCT04971226?
The interventions under investigation include: Dasatinib (DRUG), Bosutinib (DRUG), Nilotinib (DRUG), Imatinib (DRUG), Asciminib (DRUG).
Who is sponsoring clinical trial NCT04971226?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04971226 being conducted?
This trial has 20 study locations across Colorado, Florida, Kentucky, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04971226's enrollment target sits among peer trials
406 913th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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