Clinical trial
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With…
NCT04925479 · Novartis Pharmaceuticals, Industry · Recruiting
Key facts
| NCT number | NCT04925479 |
|---|---|
| Title | Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia |
| Official title | A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Recruiting |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | Myeloid Leukemia, Philadelphia Positive |
| Intervention type | Drug |
| Interventions | Asciminib Pediatric formulation group, Asciminib Adult formulation group |
| Enrollment | 44 |
| Start date | Dec 27, 2021 |
| Primary completion | Jun 30, 2026 |
| Completion | Nov 1, 2031 |
| First posted | Jun 14, 2021 |
| Last update posted | Sep 17, 2025 |
| Countries | China, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, Poland, Russia, South Korea, Thailand and 2 more |
At a glance
- 10–99 Study sites
- No Results posted
- 1–9 FDA inspections linked to this trial
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: