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NCT03578367 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT03578367: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03578367 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03578367, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP). An asciminib single agent arm (80 mg daily) was added after the primary analysis to evaluate if asciminib alone could lead to MR4.5 patients in Imatinib for at least one year who have never achieved deep molecular response (DMR).
Primary Outcome
Percentage of participants still treated with the randomized treatment at 48 weeks and are in MR\^4.5 (BCR::ABL1 ratio of ≤ 0.0032%) at 48 weeks (± assessment window), among all participants in the asciminib add-on arms vs imatinib arm.
Interventions
- DRUG Nilotinib
- DRUG Imatinib
- DRUG Asciminib add-on
- DRUG Asciminib 80mg QD (asciminib single agent (ASAC))
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2018-11-22 |
| Est. Completion | 2025-02-26 |
| Phase | Phase 2 |
What the finished NCT03578367 record still lists
NCT03578367 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Nilotinib is the first listed.
NCT03578367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03578367 about?
NCT03578367 is a clinical study titled "Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.". To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP). An asciminib single agent arm (80 mg daily) was added after t...
What is the current status of trial NCT03578367?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2018-11-22. Estimated completion is 2025-02-26.
What interventions are being tested in trial NCT03578367?
The interventions under investigation include: Nilotinib (DRUG), Imatinib (DRUG), Asciminib add-on (DRUG), Asciminib 80mg QD (asciminib single agent (ASAC)) (DRUG).
Who is sponsoring clinical trial NCT03578367?
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 NCT03578367's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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