VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML

Starting soon · Phase 3

Conditions studied: AML, Adult

In brief

This is a multicenter, randomized, controlled, open-label phase III trial evaluating the efficacy and safety of the VAG regimen (azacitidine, venetoclax, and gilteritinib) compared with standard 3+7 chemotherapy (cytarabine plus daunorubicin or idarubicin) combined with gilteritinib in newly diagnosed, fit patients with FLT3-mutated acute myeloid leukemia (AML). A total of 300 patients aged ≥14 to \<75 years with FLT3-ITD or FLT3-TKD mutations will be enrolled and randomized 1:1 to the experimental or control arm, stratified by age (≤60 vs. \>60 years). The primary endpoint is event-free survival (EFS). Secondary endpoints include composite complete remission (CRc) rate, minimal residual disease (MRD) negativity rate by flow cytometry and NGS, overall survival (OS), relapse-free survival (RFS), and 30-day and 60-day mortality.

Key facts

Study ID

NCT07407140

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

300

Starts

2026-04-30

Expected to finish

2030-12-31

Last updated by the study team

2026-03-25

Who can join

Age: 14 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed AML (excluding CBF-AML and APL) or MDS/AML (with 10%-20% marrow blasts) per WHO 2022 or ICC criteria
• Documented FLT3-ITD or FLT3-TKD mutation by PCR or NGS
• Age ≥14 and <75 years
• Eligible for intensive chemotherapy
• ECOG performance status 0-2
• Adequate organ function (liver, kidney, cardiac)
• Written informed consent

You may not qualify if…

• Acute promyelocytic leukemia with PML-RARA
• Core-binding factor AML (RUNX1-RUNX1T1 or CBFB-MYH11)
• BCR-ABL positive AML
• Prior induction chemotherapy for AML (hydroxyurea allowed)
• Concurrent active malignancy requiring therapy
• Active/symptomatic cardiac disease
• Severe uncontrolled infection
• Any condition deemed unsuitable by the investigator

Full record on ClinicalTrials.gov

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