Overview

Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

Status:
Recruiting
Trial end date:
2029-11-19
Target enrollment:
Participant gender:
Summary
The aim of this study is to support development of asciminib in the pediatric population (1 to <18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Niacinamide