[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603143":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":46,"locations":51,"responsibleParty":67,"collaborators":28,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":28,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":28,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"D\u002FIA (Daunorubicin\u002FIdarubicin + Cytarabine)","ACTIVE_COMPARATOR","Induction Cycle 1:\n\n* Cytarabine: 100 mg\u002Fm²\u002Fday, days 1-7\n* Daunorubicin: 60 mg\u002Fm²\u002Fday, days 1-3 or\n* Idarubicin: 12 mg\u002Fm²\u002Fday, days 1-3\n\n  • Induction Cycle 2 (if CR\u002FCRi\u002FCRh not achieved after Cycle 1):\n* Cyclophosphamide: 350 mg\u002Fm²\u002Fday, days 2 and 5o Cytarabine: 100 mg\u002Fm²\u002Fday, days 1-7\n* Daunorubicin: 45 mg\u002Fm²\u002Fday, days 1-2 or\n* Idarubicin: 8 mg\u002Fm²\u002Fday, days 1-2\n\nConsolidation Therapy\n\n• Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles\n\nMaintenance Therapy\n\n* Low\u002FIntermediate-Risk Patients:\n\n  1. DA\u002FIA \"2+5\" Regimen, 2 cycles Cytarabine: 100 mg\u002Fm²\u002Fday, days 1-5 Daunorubicin: 30 mg\u002Fm²\u002Fday, days 1-2 or Idarubicin: 8 mg\u002Fm²\u002Fday, days 1-2\n  2. VA Regimen, 4 cycles Azacitidine: 75 mg\u002Fm²\u002Fday, days 1-5 Venetoclax: 400 mg\u002Fday, days 1-7, oral\n* High-Risk Patients:\n\nVA Regimen, 6 cycles\n\nAllogeneic Transplantation:\n\nRecommended for high-risk patients and those with persistent MRD positivity.",[13,14,15,16],"Drug: Daunorubicin\u002FIdarubicin","Drug: Cytarabine","Drug: Azacitidine","Drug: Venetoclax",{"label":18,"type":19,"description":20,"interventionNames":21},"VA Regimen","EXPERIMENTAL","Induction Cycles\n\n* Azacitidine: 75 mg\u002Fm²\u002Fday, days 1-7\n* Venetoclax:\n\nDay 1: 100 mg Day 2: 200 mg Days 3-21: 400 mg\u002Fday If bone marrow blasts \\>5% on day 21, extend to day 28 with 400 mg\u002Fday\n\n• Efficacy will be assessed after 2 cycles. If CR\u002FCRi\u002FCRh is not achieved but the investigator believes continued treatment is beneficial, up to 4 cycles may be administered.\n\nConsolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles\n\nMaintenance Therapy\n\n* Low\u002FIntermediate-Risk Patients:\n\n  1: DA\u002FIA \"2+5\" Regimen, 2 cycles Cytarabine: 100 mg\u002Fm²\u002Fday, days 1-5 Daunorubicin: 30 mg\u002Fm²\u002Fday, days 1-2 or Idarubicin: 8 mg\u002Fm²\u002Fday, days 1-2\n\n  2.VA Regimen, 4 cycles Azacitidine: 75 mg\u002Fm²\u002Fday, days 1-5 Venetoclax: 400 mg\u002Fday, days 1-7, oral\n* High-Risk Patients:\n\n  * VA Regimen, 6 cycles\n\nAllogeneic Transplantation:\n\nRecommended for high-risk patients and those with persistent MRD positivity.",[14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Daunorubicin\u002FIdarubicin","Daunorubicin\u002FIdarubicin is used in Induction Therapy and Maintenance Therapy.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Cytarabine","Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.",[9,18],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Azacitidine","Azacitidine is used in VA regimen",[9,18],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Venetoclax","Venetoclax is used in VA regimen",[9,18],[42],{"name":43,"affiliation":44,"role":45},"Hui Wei, MD","Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College","PRINCIPAL_INVESTIGATOR",[47],{"name":43,"role":48,"phone":49,"phoneExt":28,"email":50},"CONTACT","13132507161","weihui@ihcams.ac.cn",[52],{"facility":53,"status":54,"city":55,"state":28,"zip":28,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Blood Diseases Hospital","RECRUITING","Tianjin","China","CN",{"type":59,"coordinates":60},"Point",[61,62],117.17667,39.14222,{"lat":62,"lon":61},[65],{"name":43,"role":48,"phone":66,"phoneExt":28,"email":50},"86-13132507161",{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100603143","phase-3-comparison-of-va-and-dia-induction-regimens-in-elderly-fit-acute-myeloid-leukemia-patients-100603143",false,"NCT07132684","Comparison of VA and D\u002FIA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients","A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D\u002FIA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy","Inclusion Criteria:\n\n* Diagnosis of AML according to WHO (2022) or ICC criteria.\n* Age ≥55 and ≤75 years.\n* ECOG performance status score of 0-2.\n* Adequate organ function:\n\n  * Total bilirubin ≤1.5× upper limit of normal (ULN)\n  * AST and ALT ≤2.5× ULN\n  * Serum creatinine \\\u003C2× ULN\n  * Cardiac enzymes \\\u003C2× ULN\n  * Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML-RARA fusion gene.\n* AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.\n* AML with BCR-ABL fusion gene.\n* Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).\n* Concurrent other malignancies requiring treatment.\n* Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).\n* Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).\n* Other conditions deemed unsuitable by the investigator.","ALL","55 Years","75 Years",{"count":80,"type":81},240,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D\u002FIA (Daunorubicin\u002FIdarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.",[87],"AML, Adult",[89,90,91],"acute myeloid leukemia","Older fit patients","venetoclax","2026-02-26",{"date":94,"type":95},"2026-03-02","ACTUAL",{"date":97,"type":95},"2025-08-31",{"date":99,"type":81},"2028-08-30",{"name":5,"class":6},1]