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Venetoclax added to ivosidenib and azacitidine for newly diagnosed IDH1-mutated AML in patients unfit for intensive chemotherapy
NL-OMON58822Phase 3Recruiting
- Sponsor
- HOVON
- Start
- Aug 2025
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, open-label trial in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) comparing Venetoclax + ivosidenib + azacitidine with Ivosidenib + azacitidine (2 arms). Primary endpoint: Event-free survival. Started Aug 2025; status: recruiting.
02
Drugs
venetoclaxivosidenibazacitidine
03
Conditions
acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)
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