AG-120/S95031 250mg film-coated tablet
Sponsors
Servier Affaires Medicales, Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting, Institut De Recherches Internationales Servier IRIS, Groupe Francophone Des Myelodysplasies, Groupe Francophone Des Myelodysplasies
Conditions
Acute Myeloid Leukemia (AML)Acute myeloid leukemiaHypomethylating agent (HMA) naive myelodysplastic syndromes
Myelodysplastic Symdrome (MDS)Isocitrate deshydrogenase1 mutation-positive (IDH1m) acute myeloid leukemia (AML)Locally advancedLocally advanced or metastatic conventional chondrosarcoma with an IDH1 mutationMyelodysplastic Symdrome (MDS)Myelodysplastic syndrome
Phase 1
Phase 2
Phase 3
A single arm, open-label Phase 3b study to describe the safety and tolerability of ivosidenib in combination with azacitidine in adult patients newly diagnosed with IDH1m acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy
ALIDHE
RecruitingCTIS2022-501709-11-00
Start: 2023-06-06Target: 189Updated: 2025-10-15
A Phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib in participants ≥18 years of age with locally advanced or metastatic conventional chondrosarcoma with an IDH1 mutation, untreated or previously treated with 1 systemic treatment regimen (CHONQUER study)
RecruitingCTIS2023-508507-20-00
Start: 2025-04-03Target: 91Updated: 2026-01-07
HOVON 150 AML: A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy.
Active, not recruitingCTIS2022-502832-37-00
Start: 2019-03-01Target: 852Updated: 2025-07-02
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects ≥18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation
Active, not recruitingCTIS2024-514309-73-00
Start: 2018-02-06Target: 76Updated: 2025-10-10
A phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib (IVO) monotherapy and azacitidine (AZA) monotherapy in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation (PyramIDH study).
RecruitingCTIS2023-510155-37-00
Start: 2025-05-08Target: 26Updated: 2025-09-04
HOVON 173 AML: Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
RecruitingCTIS2024-512753-24-00
Start: 2025-08-05Target: 180Updated: 2025-12-10