AML, AdultPhase 3VAG-3+7-GNCT07407140
VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML
A Phase 3 study testing Gilteritinib + Azacitidine + Venetoclax, Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib and Re-induction Therapy in people with AML, Adult, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- AML, Adult
- What is being tested?
- Gilteritinib + Azacitidine + Venetoclax, Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib and Re-induction Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
Read the detailed description
This study is designed to investigate whether the triplet combination of azacitidine (a hypomethylating agent), venetoclax (a BCL-2 inhibitor), and gilteritinib (a FLT3 inhibitor) as induction therapy improves outcomes compared to standard intensive chemotherapy plus gilteritinib in patients with newly diagnosed FLT3-mutated AML who are fit for intensive chemotherapy.
- Conditions
- AML, Adult
- Being tested
- Gilteritinib + Azacitidine + Venetoclax, Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib, Re-induction Therapy, Consolidation Therapy, Maintenance Therapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gilteritinib + Azacitidine + VenetoclaxDrug
Patients randomized to this arm receive the novel triplet combination as first-line induction therapy. Patients who achieve complete remission (CR) will receive one repeat cycle of the induction therapy.
Cytarabine + Daunorubicin (or Idarubicin) + GilteritinibDrug
Patients randomized to this arm receive the standard "3+7" intensive chemotherapy plus gilteritinib as the control regimen.
Re-induction TherapyDrug
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 TherapyDrug
Applicable to: All patients achieving CRc (CR/CRh/CRi) following two cycles of induction in the experimental arm or one to two cycles in the control arm.
Regimen: Intermediate-dose Cytarabine followed by Gilteritinib per group-specific criteria.
Cytarabine (Both Arms):
Age <60 years: 2 g/m² IV q12h, Days 1-3. Age ≥60 years: 1 g/m² IV q12h, Days 1-3.
Gilteritinib Addition (120 mg oral, Days 4-17):
Control Arm: Administered routinely in all patients. Experimental Arm: Added only if an FLT3 mutation is detectable by NGS-based MRD testing prior to the start of each consolidation cycle.
Maintenance TherapyDrug
Applicable to: All patients who have completed consolidation therapy.
Experimental Arm: Adjusted-dose VA regimen for 6 cycles.
Azacitidine: 75 mg/m²/day, Days 1-7.
Venetoclax: 400 mg daily, Days 1-7.
Control Arm: Gilteritinib monotherapy for up to 1 year.
Gilteritinib: 120 mg daily, Days 1-365.
| Study group | Role | What they receive |
|---|---|---|
| VAG Regimen ± VA Maintenance | Experimental | 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. Receives: Drug: Gilteritinib + Azacitidine + Venetoclax; Drug: Re-induction Therapy; Drug: Consolidation Therapy; Drug: Maintenance Therapy |
| 3+7 Chemotherapy + Gilteritinib | Active comparator | 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. Receives: Drug: Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib; Drug: Re-induction Therapy; Drug: Consolidation Therapy; Drug: Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
Measured: From randomization until treatment failure, relapse after CRc, death from any cause, or last follow-up, assessed up to 3 years
Secondary outcomes (6)
Composite Complete Remission Rate
Measured: After induction therapy (approximately 4-8 weeks)
Measurable residual disease-negative CRc rate by flow cytometry
Measurable residual disease-negative CRc rate by flow cytometry after every courses therapy
Measured: At the time of achieving CRc
Measurable residual disease-negative CRc rate by NGS for FLT3-ITD
Measurable residual disease-negative CRc rate by NGS for FLT3-ITD after every courses therapy
Measured: At the time of achieving CRc
Relapse-Free Survival (RFS)
Measured: From achievement of CRc until relapse, death, or last follow-up, assessed up to 3 years
30-day and 60-day mortality
Measured: 30 and 60 days after start of induction therapy
Overall Survival (OS)
Measured: From randomization until death from any cause, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start30 Apr 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407140
- Sponsor's protocol ID
- IIT2026012
- Acronym
- VAG-3+7-G
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No