[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624246":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":46,"locations":29,"responsibleParty":52,"collaborators":29,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":29,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":29,"overallStatus":74,"whyStopped":29,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":29},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"VAG Regimen ± VA Maintenance","EXPERIMENTAL","Induction (Age \\\u003C60): Azacitidine 75 mg\u002Fm²\u002Fd d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-14; Gilteritinib 120mg d1-14. Bone marrow assessment on d14: if blasts \\>5% with active marrow, Gilteritinib and Venetoclax may extend to d21.\n\nInduction (Age ≥60): Azacitidine 75 mg\u002Fm²\u002Fd d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-7; Gilteritinib 120mg d1-7. Bone marrow assessment on d7: if blasts \\>5% with active marrow, Gilteritinib and Venetoclax may extend to d14.\n\nRe-induction (if not CR\u002FCRh\u002FCRi): Gilteritinib 80mg d1-28; Azacitidine 75 mg\u002Fm²\u002Fd d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-14 (extend to d21 if d14 blasts \\>5%).\n\nConsolidation (after CR): Azacitidine 75 mg\u002Fm²\u002Fd d1-5; Venetoclax 400mg d1-14; Gilteritinib 120mg d1-14. For 2 cycles.\n\nMaintenance: Azacitidine 75 mg\u002Fm²\u002Fd d1-5; Venetoclax 400mg d1-7. For 6 cycles.",[13,14,15,16],"Drug: Gilteritinib + Azacitidine + Venetoclax","Drug: Re-induction Therapy","Drug: Consolidation Therapy","Drug: Maintenance Therapy",{"label":18,"type":19,"description":20,"interventionNames":21},"3+7 Chemotherapy + Gilteritinib","ACTIVE_COMPARATOR","Induction: Cytarabine 100 mg\u002Fm²\u002Fd continuous IV d1-7; Daunorubicin 60 mg\u002Fm²\u002Fd (or Idarubicin 12 mg\u002Fm²\u002Fd) IV d1-3; Gilteritinib 120mg d8-21.\n\nRe-induction (if not CR\u002FCRh\u002FCRi): Cytarabine 100 mg\u002Fm²\u002Fd continuous IV d1-7 or d1-5; Daunorubicin 60 mg\u002Fm²\u002Fd (or Idarubicin 12 mg\u002Fm²\u002Fd) IV d1-3 or d1-2; Gilteritinib 120mg d8-21 or d6-19.\n\nConsolidation (after CR): Intermediate-dose Cytarabine 2 g\u002Fm² (age \\\u003C60) or 1 g\u002Fm² (age ≥60) q12h d1-3; Gilteritinib 120mg d4-17. For 3 cycles.\n\nMaintenance: Gilteritinib 120mg daily. For up to 365 days.",[22,14,15,16],"Drug: Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Gilteritinib + Azacitidine + Venetoclax","Patients randomized to this arm receive the novel triplet combination as first-line induction therapy. Patients who achieve complete remission (CR) will receive one repeat cycle of the induction therapy.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Cytarabine + Daunorubicin (or Idarubicin) + Gilteritinib","Patients randomized to this arm receive the standard \"3+7\" intensive chemotherapy plus gilteritinib as the control regimen.",[18],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Re-induction Therapy","Cytarabine 100 mg\u002Fm²\u002Fd continuous IV d1-7 or d1-5; Daunorubicin 60 mg\u002Fm²\u002Fd (or Idarubicin 12 mg\u002Fm²\u002Fd) IV d1-3 or d1-2; Gilteritinib 120mg d8-21 or d6-19.",[18,9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Consolidation Therapy","Applicable to: All patients achieving CRc (CR\u002FCRh\u002FCRi) following two cycles of induction in the experimental arm or one to two cycles in the control arm.\n\nRegimen: Intermediate-dose Cytarabine followed by Gilteritinib per group-specific criteria.\n\nCytarabine (Both Arms):\n\nAge \\\u003C60 years: 2 g\u002Fm² IV q12h, Days 1-3. Age ≥60 years: 1 g\u002Fm² IV q12h, Days 1-3.\n\nGilteritinib Addition (120 mg oral, Days 4-17):\n\nControl Arm: Administered routinely in all patients. Experimental Arm: Added only if an FLT3 mutation is detectable by NGS-based MRD testing prior to the start of each consolidation cycle.",[18,9],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Maintenance Therapy","Applicable to: All patients who have completed consolidation therapy.\n\nExperimental Arm: Adjusted-dose VA regimen for 6 cycles.\n\nAzacitidine: 75 mg\u002Fm²\u002Fday, Days 1-7.\n\nVenetoclax: 400 mg daily, Days 1-7.\n\nControl Arm: Gilteritinib monotherapy for up to 1 year.\n\nGilteritinib: 120 mg daily, Days 1-365.",[18,9],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Hui Wei, MD","CONTACT","13132507161","weihui@ihcams.ac.cn",{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100624246","phase-3-vag-versus-standard-chemotherapy-with-flt3-inhibitor-in-adult-patients-with-flt3-mutated-aml-100624246",false,"NCT07407140","VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML","A Multicenter, Randomized, Controlled Trial of a Triple-Drug Regimen (Venetoclax, Azacitidine, Gilteritinib) Followed by Intensive Chemotherapy, Versus Standard Chemotherapy Plus Gilteritinib, in Fit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia.","VAG-3+7-G","Inclusion Criteria:\n\n* Newly diagnosed AML (excluding CBF-AML and APL) or MDS\u002FAML (with 10%-20% marrow blasts) per WHO 2022 or ICC criteria\n* Documented FLT3-ITD or FLT3-TKD mutation by PCR or NGS\n* Age ≥14 and \\\u003C75 years\n* Eligible for intensive chemotherapy\n* ECOG performance status 0-2\n* Adequate organ function (liver, kidney, cardiac)\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML-RARA\n* Core-binding factor AML (RUNX1-RUNX1T1 or CBFB-MYH11)\n* BCR-ABL positive AML\n* Prior induction chemotherapy for AML (hydroxyurea allowed)\n* Concurrent active malignancy requiring therapy\n* Active\u002Fsymptomatic cardiac disease\n* Severe uncontrolled infection\n* Any condition deemed unsuitable by the investigator","ALL","14 Years","75 Years",{"count":66,"type":67},300,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","This is a multicenter, randomized, controlled, open-label phase III trial evaluating the efficacy and safety of the VAG regimen (azacitidine, venetoclax, and gilteritinib) compared with standard 3+7 chemotherapy (cytarabine plus daunorubicin or idarubicin) combined with gilteritinib in newly diagnosed, fit patients with FLT3-mutated acute myeloid leukemia (AML). A total of 300 patients aged ≥14 to \\\u003C75 years with FLT3-ITD or FLT3-TKD mutations will be enrolled and randomized 1:1 to the experimental or control arm, stratified by age (≤60 vs. \\>60 years). The primary endpoint is event-free survival (EFS). Secondary endpoints include composite complete remission (CRc) rate, minimal residual disease (MRD) negativity rate by flow cytometry and NGS, overall survival (OS), relapse-free survival (RFS), and 30-day and 60-day mortality.",[73],"AML, Adult","NOT_YET_RECRUITING","2026-03-24",{"date":77,"type":78},"2026-03-25","ACTUAL",{"date":80,"type":67},"2026-04-30",{"date":82,"type":67},"2030-12-31",{"name":5,"class":6}]