Pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors
Conditions
Brief summary
Primary PK parameters of asciminib: AUClast, AUCtau, Secondary PK parameters of asciminib: Cmax, Tmax, Ctrough.
Detailed description
Number, seriousness, severity, and causality assessments of treatment-emergent adverse events and other safety data as considered appropriate., Activity: Hematologic and molecular responses., Questionnaire on acceptability and palatability after first dose, 4 and 52 weeks., Number, seriousness, severity, and causality assessments of treatment-emergent adverse events and other safety data as considered appropriate including growth and sexual maturation assessments.
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary PK parameters of asciminib: AUClast, AUCtau, Secondary PK parameters of asciminib: Cmax, Tmax, Ctrough. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number, seriousness, severity, and causality assessments of treatment-emergent adverse events and other safety data as considered appropriate., Activity: Hematologic and molecular responses., Questionnaire on acceptability and palatability after first dose, 4 and 52 weeks., Number, seriousness, severity, and causality assessments of treatment-emergent adverse events and other safety data as considered appropriate including growth and sexual maturation assessments. | — |
Countries
France, Germany, Greece, Hungary, Italy, Netherlands, Poland
Outcome results
None listed