[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559265":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":50,"locations":56,"responsibleParty":75,"collaborators":31,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":31,"enrollmentInfo":87,"targetDuration":31,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":31,"overallStatus":59,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Triple Regimen Induction of Arm1","EXPERIMENTAL","Patients will receive induction with a triple regimen therapy: Azacitidine 75mg\u002Fm2\u002Fd d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-14",[13,14,15,16],"Drug: Venetoclax","Drug: Cytarabine","Drug: Gilteritinib","Drug: Azacitadine (AZA)",{"label":18,"type":10,"description":19,"interventionNames":20},"Triple Regimen Induction of Arm2","Patients will receive induction with a triple regimen therapy: Azacitidine 75mg\u002Fm2\u002Fd d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Triple Regimen Induction of Arm3","Patients will receive induction with a triple regimen therapy: Azacitidine 75mg\u002Fm2\u002Fd d1-7; Gilteritinib: 120mg d1-7; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7",[13,14,15,16],[26,32,38,41],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Venetoclax","Venetoclax dose and schedule determined by arms and treatment phases",[9,18,22],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Cytarabine","Consolidation therapy (3 courses):\n\nintermediate-dose cytarabine regimen :2g\u002Fm2 q12h d1-3, age \\\u003C 60 years;1g\u002Fm2 q12h d1-3, age ≥60 years.\n\nIf NGS detected FLT3 mutation before consolidation chemotherapy, gilteritinib will be added during the consolidation course at d4-17.",[9,18,22],[37],"Gilteritinib",{"type":27,"name":37,"description":39,"armGroupLabels":40,"otherNames":31},"Gilteritinib 120mg schedule determined by arms or treatment phases",[9,18,22],{"type":27,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"Azacitadine (AZA)","Azacitidine 75mg\u002Fm2\u002Fd schedule determined by treatment phases",[9,18,22],[46],{"name":47,"affiliation":48,"role":49},"Hui Wei, doctor","Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":31,"email":55},"Hui Wei, Doctor","CONTACT","13132507161","weihui@ihcams.ac.cn",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Blood Diseases Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":66,"coordinates":67},"Point",[68,69],117.17667,39.14222,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":74,"phoneExt":31,"email":55},"hui wei, MD","86-13132507161",{"type":76,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100559265","phase-1-the-efficacy-of-triple-regimen-in-newly-diagnosed-aml-patients-with-flt3-mutation-100559265",false,"NCT06561880","The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation","The Efficacy of a Triple Regimen Including Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation","FLT3AML-2024","Inclusion Criteria:\n\n1. MDS\u002FAML 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.\n2. Age ≥15 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Pass the requirements of the following laboratory tests (performed within 7 days before treatment) :\n\n1\\) 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 \\\u003C 2 times the upper limit of normal (same age); 4) Myocardial enzymes \\\u003C 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.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene\n3. Acute myeloid leukemia with BCR-ABL fusion gene\n4. Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).\n5. Concurrent malignant tumors of other organs (those requiring treatment).\n6. Active heart disease, defined as one or more of the following:\n\n1\\) 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.","ALL","14 Years",{"count":88,"type":89},66,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE1","PHASE2","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.",[96,97],"FLT3 Gene Mutation","AML","2026-05-10",{"date":100,"type":101},"2026-05-13","ACTUAL",{"date":103,"type":101},"2024-10-08",{"date":105,"type":89},"2027-08-31",{"name":5,"class":6},1]