RecruitingPhase 2NCT07259707

Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML

A Single-Center, Prospective, Single-Arm Phase II Clinical Study of Consolidation With High-Dose Cytarabine Following Deep Molecular Remission Induced by Gilteritinib Plus VA Regimen in Newly Diagnosed Intermediate-Risk Fit AML Patients With FLT3-ITD Mutation

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

25 participants

Start Date

Jan 25, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Intermediate Risk Acute Myeloid Leukemia FLT3 Internal Tandem Duplication Positive Fit Patients

Summary

This clinical trial aims to evaluate whether molecular MRD-guided chemotherapy can effectively treat FLT3-ITD mutated AML and potentially replace allogeneic hematopoietic stem cell transplantation. It primarily seeks to answer: * What is the complete remission rate after initial induction with Gilteritinib, Venetoclax, and Azacitidine? * What are the survival rates and safety of subsequent high-dose cytarabine consolidation after two cycles of this induction therapy? As a single-arm study, outcomes will be compared against historical data from standard treatments (including transplant) to assess if the new strategy is equally or more effective. Participants will: * Undergo three cycles of high-dose cytarabine consolidation after two cycles of induction therapy, contingent upon achieving deep FLT3-ITD molecular remission. * Start Gilteritinib maintenance therapy after consolidation if FLT3-ITD remains detectable, continuing until deep molecular remission is achieved again.

Eligibility

Min Age: 18 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of gilteritinib (a targeted drug) plus a chemotherapy regimen called venetoclax and azacitidine (VA) followed by consolidation chemotherapy for younger adults who have newly diagnosed acute myeloid leukemia (AML) with a specific gene mutation called FLT3-ITD. **You may be eligible if...** - You are between 18 and 60 years old - You have been newly diagnosed with AML that has the FLT3-ITD mutation - You have not yet received treatment for AML - You are in adequate physical health to receive intensive chemotherapy **You may NOT be eligible if...** - You have received prior AML treatment - You have serious heart, liver, or other organ problems - You have certain other cancers or conditions that make intensive treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGVA + HDAC Consolidation & Gilteritinib Maintenance

Phase I. Induction Therapy (2 cycles): Gilteritinib plus 80 mg, orally (po), once daily (qd), continuously from Day 1 of Cycle 1 until the end of Induction.Venetoclax + Azacitidine (VA Regimen): Azacitidine: 75 mg/m², intravenously (iv) or subcutaneously (sc), once daily on Days 1-7 of each 28-day cycle.Venetoclax: Cycle 1: Dose ramp-up: 100 mg po on Day 1, 200 mg po on Day 2, then 400 mg po once daily from Day 3 to Day 28.Subsequent Cycles: 400 mg po once daily on Days 1-28 of each 28-day cycle. Phase II. Consolidation Therapy (3 cycles): High-Dose Cytarabine (HiDAC): 3.0 g/m², intravenously (iv), over 3 hours, every 12 hours (q12h) on Days 1, 3, and 5 (total of 6 doses per cycle)；Gilteritinib: Dose increased to 120 mg, orally (po), once daily (qd), from day8 to day21. The interval of each cycle is 30 days. Phase III. Maintenance Therapy: Gilteritinib: 120 mg, orally (po), once daily (qd), continuously for up to 3 months.

Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07259707

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