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

Study acronym: VAG-3+7-G
StatusNot Yet Recruiting
PhasePhase 3
Started2026-04-30
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Status v2
Start date2026-01-30→2026-04-30
2026-02-26
Study Status, Study Description, Arms and Interventions, Outcome Measures v1
Secondary endpoints6 entries, revised
Event-FreeOverall Survival (EFSOS)
Primary endpoints1 entry, revised
OverallEvent-Free Survival (OSEFS)
Study description-162 characters
FLT3This mutationsstudy conferis poordesigned prognosisto ininvestigate AML, and resistance remains a challenge despite current FLT3 inhibitor-based therapies. Preclinical and early clinical data supportwhether the potent efficacy of the tripletriplet combination of Venetoclaxazacitidine (a hypomethylating agent), Azacitidinevenetoclax (a BCL-2 inhibitor), and Gilteritinibgilteritinib (VAGa FLT3 inhibitor). This study aims to determine if VAGas induction istherapy superiorimproves outcomes compared to standard "3+7"intensive chemotherapy plus gilteritinib in fit,patients with newly diagnosed F [...] [...]
2026-02-06
Original filing
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.
Trial Details
NCT Number NCT07407140
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions AML, Adult
Enrollment 300 participants
Start Date 2026-04-30
Primary Completion 2029-02-01 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-25