A phase II, multicenter, open-label, single arm study to evaluate the safety and efficacy of asciminib in pediatric participants newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation

Philadelphia positive Chronic Myeloid leukemia in Chronic Phase with newly diagnosed and resistant/intolerant to previous TKIs, with or without the T315I mutation

Major Molecular Response (MMR) at Week 48

• MMR at Week 96 • MMR at and by scheduled timepoints, • Hematologic, cytogenetic and other molecular responses (MRs) at and by scheduled timepoints • Time to response and duration of response (limited to the binary response endpoints), time to treatment failure, time to disease progression, event free survival, overall survival, • Incidence of treatment-emergent adverse events (TEAEs) and other safety data as considered appropriate, • Height/length, weight, bone age measured by X-Ray, Tanner staging, • PK parameters of asciminib: AUClast, AUCtau, Cmax, Tmax, Ctrough

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