Status:
RECRUITING
The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
FLT3 Gene Mutation
AML
Eligibility:
All Genders
14+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 regi...
Detailed Description
This stuay intends to conduct a multi-center, single-arm clinical study to explore the efficacy of the triple induction regimen consisting of Gilteritinib, Venetoclax, and Azacitidine in newly diagnos...
Eligibility Criteria
Inclusion
- MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.
- Age ≥15 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Pass the requirements of the following laboratory tests (performed within 7 days before treatment) :
- 1\) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3) Blood creatinine \< 2 times the upper limit of normal (same age); 4) Myocardial enzymes \< 2 times the upper limit of normal (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range.
Exclusion
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).
- Concurrent malignant tumors of other organs (those requiring treatment).
- Active heart disease, defined as one or more of the following:
- 1\) A history of uncontrolled or symptomatic angina; 2) Myocardial infarction less than 6 months after enrollment; 3) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2); 5) The ejection fraction is lower than the lower limit of the normal range. 7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 8. Those who were not considered suitable for inclusion by the researchers.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06561880
Start Date
October 8 2024
End Date
August 31 2027
Last Update
October 1 2025
Active Locations (1)
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1
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020