Status: Recruiting
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
The aim of this study is to support development of asciminib in the pediatric population (1 to \< 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.
Participants needed: 50
Trial details
Phase: Phase 2Age: 1-18Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: May 26, 2026Locations: 4
Eligibility criteria
Signed informed consent must be obtained prior to participation in the study. [+9]
Known second chronic phase (CP) of CML after previous progression to Accelerated... [+3]