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NCT03106779 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
NCT03106779 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 233 participants.
The verdict
NCT03106779, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
Study Summary
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs. Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio \> 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations. Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.
Interventions
- DRUG Bosutinib
- DRUG Asciminib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2017-10-26 |
| Est. Completion | 2024-12-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03106779
The ClinicalTrials.gov registry entry for NCT03106779 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 233 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 2 interventions - of which Bosutinib is the first listed.
NCT03106779 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03106779 about?
NCT03106779 is a clinical study titled "Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs". The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs. Patients intolerant to the most recent TKI therapy must have had BCR-...
What is the current status of trial NCT03106779?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2017-10-26. Estimated completion is 2024-12-04.
What interventions are being tested in trial NCT03106779?
The interventions under investigation include: Bosutinib (DRUG), Asciminib (DRUG).
Who is sponsoring clinical trial NCT03106779?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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