Actively Recruiting
A Single-Center, Prospective, Single-Arm Phase II Study of Consolidation With High-Dose Cytarabine Following Deep Molecular Remission Induced by Gilteritinib Plus Venetoclax and Azacitidine in Newly Diagnosed Intermediate-Risk Fit AML Patients with FLT3-ITD Mutation
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-04
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for fit patients aged 18 to 60 with newly diagnosed intermediate-risk acute myeloid leukemia (AML) that has specific FLT3-ITD mutations. The study aims to assess whether monitoring deep molecular remission can guide chemotherapy effectively and potentially allow patients to avoid allogeneic hematopoietic stem cell transplantation. The trial focuses on remission rates after initial induction therapy and survival and safety following high-dose cytarabine consolidation. The treatment involves three phases: induction therapy with gilteritinib combined with venetoclax and azacitidine (GVA regimen) for two cycles; consolidation therapy with high-dose cytarabine plus gilteritinib for three cycles if deep molecular remission is achieved; and maintenance therapy with gilteritinib alone for up to three months. Molecular remission is monitored using the sensitive "DeepScan" assay to guide therapy decisions and treatment continuation. Participants will undergo regular assessments including molecular testing to measure remission status, with follow-up monitoring over two years to evaluate survival and relapse rates. The primary outcome is the complete remission rate after two induction cycles. Secondary outcomes include molecular remission rates, overall survival, leukemia-free survival, and relapse incidence. Safety and treatment effects will be closely observed throughout the study period.
CONDITIONS
Brief Title
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before any study procedures
- Age 18 years or older and 60 years or younger at screening
- Newly diagnosed acute myeloid leukemia with FLT3-ITD mutation as per ELN 2022 criteria
- Intermediate-risk AML without low-risk or high-risk genetic features
- ECOG performance status of 0 to 2
- Biochemical indicators within specified limits: ALT and AST 3 times upper limit of normal; total bilirubin 3 times upper limit of normal; serum creatinine 2 times upper limit or creatinine clearance 40 mL/min
- Normal left ventricular ejection fraction (LVEF > 50%) by echocardiography
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia, BCR-ABL positive AML, or AML secondary to prior chemotherapy or radiotherapy
- History of other malignancies except certain treated non-malignant skin melanoma, cured in situ tumors, or solid tumors disease-free for at least 2 years
- Unfit for intensive chemotherapy due to ECOG status 3 or higher, severe cardiac or pulmonary diseases, poor kidney or liver function, or other incompatible comorbidities
- Uncontrolled fungal, bacterial, or viral infections
- Known active liver disease such as hepatitis B or C, or HIV infection
- Allergy to any excipients in gilteritinib tablets
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each cycle is typically 28 days with 2-week intervals, totaling approximately 2 months
Participants receive gilteritinib combined with venetoclax and azacitidine for 2 cycles to achieve remission and deep molecular clearance.
Multiple visits during each 28-day cycle for treatment and monitoring
Duration - 3 cycles of 30 days each, approximately 3 months
Participants who achieve deep molecular remission receive consolidation with high-dose cytarabine and gilteritinib for 3 cycles to further eliminate leukemia cells.
3 visits per cycle corresponding to dosing days plus additional monitoring visits
Duration - Up to 3 months
Participants maintaining deep molecular remission receive gilteritinib monotherapy daily for up to 3 months to sustain remission.
Regular visits during maintenance period for monitoring
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
J
Jie Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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