Actively Recruiting
The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13
66
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.
CONDITIONS
Official Title
The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have AML or MDS/AML with 10%-20% bone marrow naive cells and a FLT3-TKD or ITD mutation confirmed by PCR or sequencing.
- Participants must be 15 years or older, any gender.
- Eastern Oncology Collaboration Group performance status (ECOG-PS) between 0 and 2.
- Laboratory test results within 7 days before treatment must meet these limits: total bilirubin ≤1.5 times normal, AST and ALT ≤2.5 times normal, creatinine less than 2 times normal, myocardial enzymes less than 2 times normal.
- Normal heart ejection fraction confirmed by echocardiography (ECHO).
You will not qualify if you...
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
- AML with BCR-ABL fusion gene.
- Patients who have already received induction chemotherapy (except hydroxyurea).
- Presence of other active malignant tumors requiring treatment.
- Active heart disease including uncontrolled angina, recent myocardial infarction under 6 months, arrhythmia needing treatment, severe heart failure (NYHA >2), or low ejection fraction.
- Serious untreated infections such as tuberculosis or pulmonary aspergillosis.
- Any other condition deemed unsuitable by the researchers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
H
Hui Wei, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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