Status: Recruiting
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
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.
Participants needed: 34
Trial details
Phase: Phase 1, Phase 2Age: 1-17Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Aug 27, 2026Locations: 39
Eligibility criteria
Pediatric formulation group: ≥ 1 and less than 18 years of age at study entry. [+12]
Known presence of the T315I mutation prior to study entry or a BCR::ABL mutation... [+9]