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

연구 개요

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.

스폰서
리드: 노바티스
적응증
Myeloid Leukemia, Philadelphia Positive
중재
Asciminib Pediatric formulation group, Asciminib Adult formulation group
목표 등록
34
시작일
2021-12-27
완료(예정)
2031-11-01

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