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drugset / Trial / NCT04925479

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

NCT04925479 ↗

Phase 1/2 Recruiting 34 enrolled Novartis Pharmaceuticals
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2021-12-27
Primary completion
2027-09-21
Completion
2031-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Asciminib Unknown 1.3 mg/kg Oral
Subject Asciminib Unknown 2.6 mg/kg Oral
Subject Asciminib Unknown 10 mg Oral
Subject Asciminib Unknown 15 mg Oral
Subject Asciminib Unknown 20 mg Oral
Subject Asciminib Unknown 30 mg Oral
Subject Asciminib Unknown 40 mg Oral

Indications

Philadelphia-positive myelogenous leukemia