Trial intelligence / Profile preview

Revumenib added to azacitidine + venetoclax for newly diagnosed NPM1-mutated or KMT2A-rearranged AML in adults ineligible for intensive chemotherapy

NL-OMON58913Phase 3Recruiting

Sponsor
HOVON
Start
Mar 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
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Overview

Phase 3, randomised, open-label trial in acute myeloid leukemia (AML) comparing Revumenib + azacitidine + venetoclax with Azacitidine + venetoclax (2 arms). Primary endpoints: Overall survival in NPM1-mutated AML and Complete remission rate in NPM1-mutated AML. Started Mar 2025; status: recruiting.

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Drugs

revumenibvenetoclaxazacitidine
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Conditions

acute myeloid leukemia (AML)

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