VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML
Summary
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.
Timeline
- Start
- 2026-04-30
- Primary completion
- 2029-02-01
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 1 g | Intravenous |
| Comparator | Cytarabine | Small molecule | 2 g | Intravenous |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Gilteritinib | Small molecule | 80 mg | Oral |
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |
| Comparator | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | — |