ASCIMINIB HYDROCHLORIDE
Sponsors
Novartis Pharma AG
Conditions
Chronic Myelogenous Leukemia in chronic phase (CML-CP)Chronic Myeloid LeukemiaPediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)Ph+) or BCR::ABL1-like (Ph-like) acute lymphoblastic leukemia (ALL)Philadelphia positive Chronic Myeloid leukemia in Chronic Phase with newly diagnosed and resistant/intolerant to previous TKIspreviously treated with one or more tyrosine kinase inhibitorsrelapsed or refractory BCR::ABL1-positive (Philadelphia positivewith or without the T315I mutation
Phase 1
A multi-center, open-label study to determine the dose and safety of oral asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors.
RecruitingCTIS2023-508129-28-00
Start: 2022-09-28Target: 17Updated: 2025-07-30
A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
Not yet recruitingCTIS2025-522019-40-00
Target: 9Updated: 2026-04-28
Phase 2
Phase 3
A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Active, not recruitingCTIS2023-508838-33-00
Start: 2021-10-06Target: 159Updated: 2026-01-22
A phase IIIb, multi-center, open-label, treatment optimization study of oral
asciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CMLCP)
previously treated with 2 or more tyrosine kinase inhibitors
Active, not recruitingCTIS2024-511381-36-00
Start: 2021-10-13Target: 108Updated: 2025-10-20
A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Active, not recruitingCTIS2024-510947-71-00
Start: 2022-11-21Target: 383Updated: 2026-01-20