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., Grupo Espanol De Leucemia Mieloide Cronica (GELMC)
Conditions
BCR-ABL1+ Chronic Myeloid LeukemiaCML-CP or CML-AP patients with T315I mutationChronic Myelogenous Leukemia in chronic phase (CML-CP)Chronic Myeloid LeukemiaChronic 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
Safety and efficacy of treatment combination with ponatinib and asciminib in chronic myeloid leukemia patients resistant to ponatinib and/or asciminib
Not yet recruitingCTIS2025-521126-15-00
Target: 30Updated: 2026-06-01