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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07407140
- Acronym / sponsor ID
- VAG-3+7-G / IIT2026012
- Conditions
- AML, Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAG Regimen ± VA Maintenance | Experimental | Drug: Gilteritinib + Azacitidine + Venetoclax, Drug: Re-induction Therapy, Drug: Consolidation Therapy, Drug: Maintenance TherapyInduction (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. |
| 3+7 Chemotherapy + Gilteritinib | Active comparator | Drug: Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib, Drug: Re-induction Therapy, Drug: Consolidation Therapy, Drug: Maintenance TherapyInduction: 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. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gilteritinib + Azacitidine + VenetoclaxPatients 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. | Drug | VAG Regimen ± VA Maintenance |
| Cytarabine + Daunorubicin (or Idarubicin) + GilteritinibPatients randomized to this arm receive the standard "3+7" intensive chemotherapy plus gilteritinib as the control regimen. | Drug | 3+7 Chemotherapy + Gilteritinib |
| Re-induction TherapyCytarabine 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. | Drug | 3+7 Chemotherapy + Gilteritinib, VAG Regimen ± VA Maintenance |
| Consolidation TherapyApplicable 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. | Drug | 3+7 Chemotherapy + Gilteritinib, VAG Regimen ± VA Maintenance |
| Maintenance TherapyApplicable 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. | Drug | 3+7 Chemotherapy + Gilteritinib, VAG Regimen ± VA Maintenance |
Primary outcome
Event-Free Survival (EFS)
Time frame: From randomization until treatment failure, relapse after CRc, death from any cause, or last follow-up, assessed up to 3 years
6 secondary outcomes
Composite Complete Remission Rate
Time frame: After induction therapy (approximately 4-8 weeks)
Measurable residual disease-negative CRc rate by flow cytometry
Time frame: At the time of achieving CRc
Measurable residual disease-negative CRc rate by NGS for FLT3-ITD
Time frame: At the time of achieving CRc
Relapse-Free Survival (RFS)
Time frame: From achievement of CRc until relapse, death, or last follow-up, assessed up to 3 years
30-day and 60-day mortality
Time frame: 30 and 60 days after start of induction therapy
Overall Survival (OS)
Time frame: From randomization until death from any cause, assessed up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Wei, MD (13132507161, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: From randomization until treatment failure, relapse after CRc, death from any cause, or last follow-up, assessed up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.