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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 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 104 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03578367
The ClinicalTrials.gov registry entry for NCT03578367 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Nilotinib is the first listed.
NCT03578367 reports 0 study locations.
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.
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