Trial intelligence / Profile preview

Venetoclax + azacitidine + quizartinib versus venetoclax + azacitidine in newly diagnosed AML ineligible for intensive induction

2025-522979-29-00Phase 3Authorised

Sponsor
PETHEMA
Start
Apr 2026
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
3
01

Overview

Phase 3, randomised, open-label trial in acute myeloid leukemia (AML) comparing Quizartinib + venetoclax + azacitidine with Venetoclax + azacitidine (2 arms). Primary endpoint: Overall survival. Planned start Apr 2026; status: authorised.

02

Drugs

quizartinibvenetoclaxazacitidine
03

Conditions

acute myeloid leukemia (AML)

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