Scemblix 40 mg film-coated tablets
Sponsors
Fondazione Gimema Franco Mandelli Onlus, Grupo Espanol De Leucemia Mieloide Cronica (GELMC), Novartis Pharma AG, Novartis Pharma S.A.S., Novartis Farma S.p.A.
Conditions
BCR-ABL1+ Chronic Myeloid LeukemiaCML-CP or CML-AP patients with T315I mutationChronic Myelogenous Leukemia in chronic phase (CML-CP)Chronic myeloid leukemiapreviously treated with imatinib and have not achieved deep molecular response
Phase 2
A phase II, single-arm study of de-escalation and treatment-free remission in patients with chronic myeloid leukemia treated with nilotinib in first-line therapy followed by a second attempt after nilotinib and asciminib combination: DANTE study
CompletedCTIS2024-516122-66-00
Start: 2019-01-18End: 2025-10-15Target: 170Updated: 2025-07-09
A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treated with imatinib and have not achieved deep molecular response
CompletedCTIS2024-515040-23-00
Start: 2018-11-26End: 2025-02-26Target: 37Updated: 2025-02-18
A Phase II, multi-center, prospective, open-label study of Asciminib in patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) or accelerated Phase (CML-AP) with T315I mutation who are resistant, intolerant or ineligible to ponatinib (ASC4TARGET)
RecruitingCTIS2024-516049-38-00
Start: 2025-02-18Target: 20Updated: 2025-10-01
Asciminib as single agent or in combination with nilotinib in the 1st-line treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a GIMEMA-GELMC phase II study. CML1624
RecruitingCTIS2024-512696-12-00
Start: 2025-06-24Target: 160Updated: 2025-11-17