drugset / Trial / NCT04666259

Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation

NCT04666259

Phase 3 Completed 56 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI

Timeline

Start
2021-05-25
Primary completion
2023-06-20
Completion
2024-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Asciminib Unknown 40 mg Oral
Subject Asciminib Unknown 80 mg Oral
Subject Asciminib Unknown 200 mg Oral