Clinical Trial

Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 16 -> 24 locations 2026-07-25
notable Trial sites expanded: 4 -> 16 locations 2026-07-10
critical Recruitment opened 2026-04-25
Trial Details
NCT Number NCT07354074
Lead Sponsor Novartis Pharmaceuticals
Conditions Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
Enrollment 50 participants
Start Date 2026-04-28
Primary Completion 2033-02-23 (estimated)
Study Completion 2033-02-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-24