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VAG-3+7-GTriple-Drug Regimen (Venetoclax, Azacitidine, Gilteritinib) for Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia

Study Aim

This study aims to evaluate the effectiveness of a triple-drug regimen (Venetoclax, Azacitidine, Gilteritinib) on extending the overall survival in individuals newly diagnosed with FLT3-Mutated Acute Myeloid Leukemia.

What is being tested

Gilteritinib + Azacitidine + Venetoclax

+ Re-induction Therapy

+ Consolidation Therapy

Drug

Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

From 14 to 75 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorInstitute of Hematology & Blood Diseases Hospital, China

Study ContactHui Wei, MD

Last updated: February 13, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 30, 2026

Actual date on which the first participant was enrolled.

Acute Myeloid Leukemia (AML) with FLT3 mutations often has a poor outlook, and current treatments using FLT3 inhibitors still face resistance challenges. Early research suggests that a combination of three drugs - Venetoclax, Azacitidine, and Gilteritinib (VAG) - could offer powerful benefits. This study focuses on fit adults newly diagnosed with FLT3-mutated AML, aiming to discover if starting treatment with VAG is more effective than the standard chemotherapy combined with Gilteritinib. The importance of this study lies in its potential to improve care and address current challenges for patients with this specific type of leukemia.

Official TitleA 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.

NCT07407140

Principal SponsorInstitute of Hematology & Blood Diseases Hospital, China

Study ContactHui Wei, MD

Last updated: February 13, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 14 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

7 inclusion criteria required to participate

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

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8 exclusion criteria prevent from participating

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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Venetoclax (oral, dose ramp-up: 100 mg D1, 200 mg D2, 400 mg D3 onward), Azacitidine (75 mg/m²/day, D1-7), and Gilteritinib (120 mg daily) are administered as follows: Age \<60 years: Venetoclax and Gilteritinib are given from D1-14. A bone marrow aspirate on D14 is required. If blasts are \>5% with hypercellular marrow, both drugs may be extended to D21. Age ≥60 years: Venetoclax and Gilteritinib are given from D1-7. A bone marrow aspirate on D7 is required. If blasts are \>5% with hypercellular marrow, both drugs may be extended to D14.

Group II

Active Comparator

Cytarabine (100 mg/m²/day continuous infusion, days 1-7) + Daunorubicin (60 mg/m²/day, days 1-3) OR Idarubicin (12 mg/m²/day, days 1-3)+ Gilteritinib (120mg, d8-21)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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