Xospata 40 mg film-coated tablets
Sponsors
French Innovative Leukemia Organization, Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting, Centre Antoine Lacassagne, Technische Universitat Dresden, Fondazione Gimema Franco Mandelli Onlus
Conditions
Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML)Acute myeloid leukaemiaAcute myeloid leukemiaMDS-EB2Patients aged 18 years and older with relapsed or refractory FLT3 mutated acute myeloid leukemianewly diagnosed non-M3 FLT3-positive acute myeloid leukemia
Phase 1
Phase 2
FILOAML-RR-01-OGILAR: Open-label, phase 2 study investigating the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed/refractory FLT3-mutated acute myeloid leukemia
Active, not recruitingCTIS2022-501372-25-00
Start: 2024-01-10Target: 33Updated: 2025-12-17
HOVON 156 AML: A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy.
Active, not recruitingCTIS2022-502478-18-00
Start: 2019-12-20Target: 697Updated: 2025-10-21
Sequential Gilteritinib in Combination with Venetoclax and Azacitidine for Patients with Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutations Ineligible for Intensive Treatment (SEQUENCE)
RecruitingCTIS2023-507878-41-00
Start: 2025-04-25Target: 60Updated: 2025-10-02
A Phase II, Open-Label, multicentre, study investigating tolerability and efficacy of Gilteritinib in combination with fludarabine, cytarabine and idarubicin (FLAI) as induction therapy of newly diagnosed non-M3 FLT3-positive acute myeloid leukemia.GIMEMA AML2924
Not yet recruitingCTIS2024-518617-25-00
Target: 80Updated: 2025-10-23
An open-label, phase 2 study, evaluating the efficacy of treatment with Gilteritinib in measurable residual disease eradication in patients with FLT3-ITD mutated acute myeloid leukemia
Not yet recruitingCTIS2025-521875-30-00
Target: 58Updated: 2025-11-20