NCT07407140Not yet recruitingPhase 3
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 · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- 30 Apr 2026
- Primary completion date
- 1 Feb 2029
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07407140
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 30 Apr 2026 to the primary completion date, 1 Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior induction chemotherapy for AML (hydroxyurea allowed)
- Concurrent active malignancy requiring therapy
Other illness
- Active/symptomatic cardiac disease
- Severe uncontrolled infection
- Any condition deemed unsuitable by the investigator
Other
- Acute promyelocytic leukemia with PML-RARA
- Core-binding factor AML (RUNX1-RUNX1T1 or CBFB-MYH11)
- BCR-ABL positive AML
Who the study is looking for
- 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
Age in the registry: 14 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.