Actively Recruiting
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-04
25
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 before study procedures
- Age 18 to 60 years at screening
- Newly diagnosed acute myeloid leukemia with FLT3-ITD mutation and intermediate-risk features per ELN 2022 criteria
- ECOG performance status 0 to 2
- Liver enzymes (ALT and AST) no more than 3 times the upper limit of normal
- Total bilirubin no more than 3 times the upper limit of normal
- Serum creatinine no more than twice the upper limit of normal or creatinine clearance at least 40 mL/min
- Left ventricular ejection fraction greater than 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 cancers except treated non-malignant skin melanoma, cured in situ tumors, or other solid tumors with no disease for at least 2 years
- Unfit for intensive chemotherapy including ECOG 2 or higher, severe heart or lung disease, impaired kidney or liver function, or other comorbidities
- Uncontrolled fungal, bacterial, or viral infections
- Active liver disease such as hepatitis B or C
- Known HIV infection
- Allergy to any ingredients in gilteritinib tablets
- Pregnant or breastfeeding women
- Any other condition considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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