Trial intelligence / Profile preview

PyramIDH: Ivosidenib vs azacitidine monotherapy in HMA-naive IDH1-mutated MDS

jRCT2051240209Phase 3Recruiting

Sponsor
Servier
Start
Dec 2024
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
01

Overview

Phase 3, randomised, open-label trial in myelodysplastic syndrome (MDS) comparing Ivosidenib monotherapy with Azacitidine monotherapy (2 arms). Primary endpoint: Complete response + partial response rate at 4 months. Started Dec 2024; status: recruiting.

02

Drugs

ivosidenibazacitidine
03

Conditions

myelodysplastic syndrome (MDS)

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