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NCT04666259 · ClinicalTrials.gov registry record · Phase 3
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT04666259: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04666259 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 56 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04666259, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI
Primary Outcome
Adverse events (AEs) and serious adverse events (SAEs) are summarized by cohort. Clinically significant findings for vitals, laboratory values and electrocardiogram (ECG) are reported as adverse events and or serious adverse events as determined by the investigator.
Interventions
- DRUG ABL001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2024-06-26 |
| Phase | Phase 3 |
What the finished NCT04666259 record still lists
NCT04666259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which ABL001 is the first listed.
NCT04666259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04666259 about?
NCT04666259 is a clinical study titled "Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation". This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI
What is the current status of trial NCT04666259?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2021-05-25. Estimated completion is 2024-06-26.
What interventions are being tested in trial NCT04666259?
The interventions under investigation include: ABL001 (DRUG).
Who is sponsoring clinical trial NCT04666259?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04666259's enrollment target sits among peer trials
56 1827th of 2000 higher than 167 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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