Trial Profile

A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 16 May 2025

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At a glance

Drugs Azacitidine (Primary) ; Gilteritinib (Primary) ; Venetoclax (Primary)
Indications Acute myeloid leukaemia
Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
Acronyms VICEROY
Sponsors Astellas Pharma Global Development

16 Jun 2024 Trial design were presented at the 29th Congress of the European Haematology Association.
23 May 2023 Planned End Date changed from 30 Apr 2028 to 31 Jul 2028.
23 May 2023 Planned primary completion date changed from 30 Apr 2028 to 31 Jul 2028.

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