Clinical trial · Interventional
VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML
A Multicenter, Randomized, Controlled Trial of a Triple-Drug Regimen (Venetoclax, Azacitidine, Gilteritinib) Followed by Intensive Chemotherapy, Versus Standard Chemotherapy Plus Gilteritinib, in Fit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidation Therapy | Drug | — | UNRESOLVED |
| Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib | Drug | — | UNRESOLVED |
| Gilteritinib + Azacitidine + Venetoclax | Drug | — | UNRESOLVED |
| Maintenance Therapy | Drug | — | UNRESOLVED |
| Re-induction Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VAG Regimen ± VA Maintenance
- description
- Induction (Age \<60): Azacitidine 75 mg/m²/d d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-14; Gilteritinib 120mg d1-14. Bone marrow assessment on d14: if blasts \>5% with active marrow, Gilteritinib and Venetoclax may extend to d21. Induction (Age ≥60): Azacitidine 75 mg/m²/d d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-7; Gilteritinib 120mg d1-7. Bone marrow assessment on d7: if blasts \>5% with active marrow, Gilteritinib and Venetoclax may extend to d14. Re-induction (if not CR/CRh/CRi): Gilteritinib 80mg d1-28; Azacitidine 75 mg/m²/d d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-14 (extend to d21 if d14 blasts \>5%). Consolidation (after CR): Azacitidine 75 mg/m²/d d1-5; Venetoclax 400mg d1-14; Gilteritinib 120mg d1-14. For 2 cycles. Maintenance: Azacitidine 75 mg/m²/d d1-5; Venetoclax 400mg d1-7. For 6 cycles.
- interventionNames
- Drug: Gilteritinib + Azacitidine + Venetoclax
- Drug: Re-induction Therapy
- Drug: Consolidation Therapy
- Drug: Maintenance Therapy
- type
- ACTIVE_COMPARATOR
- label
- 3+7 Chemotherapy + Gilteritinib
- description
- Induction: Cytarabine 100 mg/m²/d continuous IV d1-7; Daunorubicin 60 mg/m²/d (or Idarubicin 12 mg/m²/d) IV d1-3; Gilteritinib 120mg d8-21. Re-induction (if not CR/CRh/CRi): Cytarabine 100 mg/m²/d continuous IV d1-7 or d1-5; Daunorubicin 60 mg/m²/d (or Idarubicin 12 mg/m²/d) IV d1-3 or d1-2; Gilteritinib 120mg d8-21 or d6-19. Consolidation (after CR): Intermediate-dose Cytarabine 2 g/m² (age \<60) or 1 g/m² (age ≥60) q12h d1-3; Gilteritinib 120mg d4-17. For 3 cycles. Maintenance: Gilteritinib 120mg daily. For up to 365 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available