[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630346":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":292,"collaborators":294,"id":298,"slug":299,"hasResults":300,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":29,"eligibilityCriteria":304,"healthyVolunteers":300,"sex":305,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":29,"studyType":311,"phases":312,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":321,"whyStopped":29,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"MVA","EXPERIMENTAL","Patients achieving complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) after Cycle 1 proceed to consolidation therapy.\n\nPatients achieving a partial response (PR) or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same MVA regimen.\n\nThose who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation.\n\nPatients with no response (NR) after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.",[13,14,15],"Drug: Mitoxantrone Hydrochloride Liposome","Drug: Venetoclax","Drug: Azacitidine",{"label":17,"type":18,"description":19,"interventionNames":20},"IA","ACTIVE_COMPARATOR","Patients achieving CR, CRh, CRi, or MLFS after Cycle 1 proceed to consolidation therapy.\n\nPatients achieving a PR or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same IA regimen.\n\nThose who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation.\n\nPatients with NR after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.",[21,22],"Drug: Idarubicin","Drug: Cytarabine",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Mitoxantrone Hydrochloride Liposome","Mitoxantrone Hydrochloride Liposome: 24 mg\u002Fm², administered by intravenous drip (ivgtt) on day 1",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Venetoclax","Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po)",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Azacitidine","Azacitidine: 75 mg\u002Fm², administered subcutaneously (sc) on days 1-7",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Idarubicin","Idarubicin: 12 mg\u002Fm², administered by intravenous drip (ivgtt) on days 1-3",[17],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Cytarabine","Cytarabine: 100 mg\u002Fm², administered by intravenous drip (ivgtt) on days 1-7",[17],[47],{"name":48,"affiliation":5,"role":49},"Depei Wu","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":29,"email":55},"Xiaowen Tang","CONTACT","0512-67780103","tangxiaowen@suda.edu.cn",[57,73,86,99,107,120,132,144,156,165,177,185,192,204,211,222,234,246,255,267,280],{"facility":58,"status":29,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"The First Affiliated Hospital of Anhui Medical University","Hefei","Anhui","230022","China","CN",{"type":65,"coordinates":66},"Point",[67,68],117.28083,31.86389,{"lat":68,"lon":67},[71],{"name":72,"role":49,"phone":29,"phoneExt":29,"email":29},"Mingzhen Yang",{"facility":74,"status":29,"city":75,"state":76,"zip":77,"country":62,"countryCode":63,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"The First Affiliated Hospital of Henan University of Science and Technology","Luoyang","Henan","41003",{"type":65,"coordinates":79},[80,81],112.43684,34.67345,{"lat":81,"lon":80},[84],{"name":85,"role":49,"phone":29,"phoneExt":29,"email":29},"Ling Qin",{"facility":87,"status":29,"city":88,"state":89,"zip":90,"country":62,"countryCode":63,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430030",{"type":65,"coordinates":92},[93,94],114.26667,30.58333,{"lat":94,"lon":93},[97],{"name":98,"role":49,"phone":29,"phoneExt":29,"email":29},"Zhenya Hong",{"facility":100,"status":29,"city":88,"state":89,"zip":29,"country":62,"countryCode":63,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"Renmin Hospital of Wuhan University",{"type":65,"coordinates":102},[93,94],{"lat":94,"lon":93},[105],{"name":106,"role":49,"phone":29,"phoneExt":29,"email":29},"Baixin Ye",{"facility":108,"status":29,"city":109,"state":110,"zip":111,"country":62,"countryCode":63,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Changzhou First People's Hospital","Changzhou","Jiangsu","213003",{"type":65,"coordinates":113},[114,115],119.95401,31.77359,{"lat":115,"lon":114},[118],{"name":119,"role":49,"phone":29,"phoneExt":29,"email":29},"Weiying Gu",{"facility":121,"status":29,"city":122,"state":110,"zip":123,"country":62,"countryCode":63,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Huai'an Second People's Hospital","Huai'an","223002",{"type":65,"coordinates":125},[126,127],119.01917,33.58861,{"lat":127,"lon":126},[130],{"name":131,"role":49,"phone":29,"phoneExt":29,"email":29},"Yanming Zhang",{"facility":133,"status":29,"city":134,"state":110,"zip":135,"country":62,"countryCode":63,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Jingjiang People's Hospital","Jingjiang","214500",{"type":65,"coordinates":137},[138,139],120.2625,32.01417,{"lat":139,"lon":138},[142],{"name":143,"role":49,"phone":29,"phoneExt":29,"email":29},"Miao Sun",{"facility":145,"status":29,"city":146,"state":110,"zip":147,"country":62,"countryCode":63,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"The First People's Hospital Of Lianyungang","Lianyungang","222002",{"type":65,"coordinates":149},[150,151],119.21556,34.59845,{"lat":151,"lon":150},[154],{"name":155,"role":49,"phone":29,"phoneExt":29,"email":29},"Ying Wang",{"facility":157,"status":29,"city":146,"state":110,"zip":158,"country":62,"countryCode":63,"cosmosGeoPoint":159,"geoPoint":161,"contacts":162},"The Second People's Hospital of Lianyungang","222006",{"type":65,"coordinates":160},[150,151],{"lat":151,"lon":150},[163],{"name":164,"role":49,"phone":29,"phoneExt":29,"email":29},"Wanchuan Zhuang",{"facility":166,"status":29,"city":167,"state":110,"zip":168,"country":62,"countryCode":63,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Jiangsu Province Hospital of Chinese Medicine","Nanjing","210029",{"type":65,"coordinates":170},[171,172],118.77778,32.06167,{"lat":172,"lon":171},[175],{"name":176,"role":49,"phone":29,"phoneExt":29,"email":29},"Xuejun Zhu",{"facility":178,"status":29,"city":167,"state":110,"zip":168,"country":62,"countryCode":63,"cosmosGeoPoint":179,"geoPoint":181,"contacts":182},"Jiangsu Province Hospital",{"type":65,"coordinates":180},[171,172],{"lat":172,"lon":171},[183],{"name":184,"role":49,"phone":29,"phoneExt":29,"email":29},"Ming Hong",{"facility":178,"status":29,"city":167,"state":110,"zip":168,"country":62,"countryCode":63,"cosmosGeoPoint":186,"geoPoint":188,"contacts":189},{"type":65,"coordinates":187},[171,172],{"lat":172,"lon":171},[190],{"name":191,"role":49,"phone":29,"phoneExt":29,"email":29},"Kourong Miao",{"facility":193,"status":29,"city":194,"state":110,"zip":195,"country":62,"countryCode":63,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Affiliated Hospital of Nantong University","Nantong","226001",{"type":65,"coordinates":197},[198,199],120.87472,32.03028,{"lat":199,"lon":198},[202],{"name":203,"role":49,"phone":29,"phoneExt":29,"email":29},"Hongming Huang",{"facility":193,"status":29,"city":194,"state":110,"zip":195,"country":62,"countryCode":63,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},{"type":65,"coordinates":206},[198,199],{"lat":199,"lon":198},[209],{"name":210,"role":49,"phone":29,"phoneExt":29,"email":29},"Zenghua 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Hospital","Yancheng","224006",{"type":65,"coordinates":239},[240,241],120.1573,33.3575,{"lat":241,"lon":240},[244],{"name":245,"role":49,"phone":29,"phoneExt":29,"email":29},"Yuexin Cheng",{"facility":247,"status":29,"city":248,"state":110,"zip":249,"country":62,"countryCode":63,"cosmosGeoPoint":250,"geoPoint":254,"contacts":29},"Northern Jiangsu People's Hospital","Yangzhou","225001",{"type":65,"coordinates":251},[252,253],119.43583,32.39722,{"lat":253,"lon":252},{"facility":256,"status":29,"city":257,"state":258,"zip":29,"country":62,"countryCode":63,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Shandong First Medical University Affiliated Tumor Hospital","Jinan","Shandong",{"type":65,"coordinates":260},[261,262],116.99722,36.66833,{"lat":262,"lon":261},[265],{"name":266,"role":49,"phone":29,"phoneExt":29,"email":29},"Ji Ma",{"facility":268,"status":29,"city":269,"state":270,"zip":271,"country":62,"countryCode":63,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang","310022",{"type":65,"coordinates":273},[274,275],120.16142,30.29365,{"lat":275,"lon":274},[278],{"name":279,"role":49,"phone":29,"phoneExt":29,"email":29},"Yamin Tan",{"facility":281,"status":29,"city":282,"state":270,"zip":283,"country":62,"countryCode":63,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"The First Affiliated Hospital of Ningbo University","Ningbo","315010",{"type":65,"coordinates":285},[286,287],121.54945,29.87819,{"lat":287,"lon":286},[290],{"name":291,"role":49,"phone":29,"phoneExt":29,"email":29},"Guifang Ouyang",{"type":293,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[295],{"name":296,"class":297},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY","100630346","phase-3-venetoclax-azacitidine-and-mitoxantrone-hydrochloride-liposome-versus-idarubicin-and-cytarabine-in-newly-diagnosed-aml-100630346",false,"NCT07486479","Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML","A Prospective, Multicenter, Randomized Controlled Clinical Study of Venetoclax Combined With Azacitidine and Mitoxantrone Hydrochloride Liposome Versus Idarubicin Combined With Cytarabine \"3+7\" in the Treatment of Newly Diagnosed AML","Inclusion Criteria:\n\n* 1\\. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF).\n\n  2\\. Aged 18 to 65 years, any gender. 3. Newly diagnosed with AML according to the 2022 WHO classification. 4. Eligible for intensive chemotherapy as determined by the investigator. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6. Life expectancy ≥ 3 months. 7. Adequate liver and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (≤ 5 × ULN for patients with hepatic involvement); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with hepatic involvement); serum creatinine ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from the study:\n\n  1. Any of the following conditions:\n\n     1. Acute promyelocytic leukemia (APL);\n     2. Central nervous system leukemia (CNSL);\n     3. AML secondary to chemotherapy\u002Fradiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML);\n  2. Prior treatment with hypomethylating agents (HMA) or venetoclax;\n  3. Prior anti-AML therapy (except for leukocytosis management such as hydroxyurea or leukapheresis);\n  4. History of other malignancies within the past 5 years (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies that have been effectively controlled without treatment in the past five years);\n  5. Inability to take oral medication or malabsorption syndrome;\n  6. Cardiac function or disease meeting any of the following criteria:\n\n     1. Long QTc syndrome or QTc interval \\> 480 ms;\n     2. Complete left bundle branch block, second- or third-degree atrioventricular block;\n     3. Severe, uncontrolled arrhythmias requiring medication;\n     4. New York Heart Association (NYHA) Class ≥ II;\n     5. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n     6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other significant arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to enrollment, or ECG evidence of acute ischemia or active conduction system abnormalities.\n  7. Uncontrolled systemic illnesses (e.g., active infection, uncontrolled hypertension, diabetes);\n  8. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);\n  9. Active Hepatitis B or C infection (Hepatitis B: HBsAg or HBcAb positive, with HBV-DNA \\> 1×10³ copies\u002FmL; Hepatitis C: HCV-Ab positive, with HCV-RNA \\> 1×10³ copies\u002FmL);\n  10. Known history of immediate or delayed hypersensitivity reaction to drugs of the same class or excipients of the investigational product;\n  11. Significant neurological or psychiatric history;\n  12. Pregnant or lactating women;\n  13. Patients considered by the investigator to be unsuitable for participation in this study.","ALL","18 Years","65 Years",{"count":309,"type":310},204,"ESTIMATED","INTERVENTIONAL",[313],"PHASE3","This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.",[316],"Acute Myeloid Leukemia (AML)",[318,319,31,35,39,43,320],"Acute myeloid leukemia","mitoxantrone hydrochloride liposome","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-03-17",{"date":324,"type":325},"2026-03-20","ACTUAL",{"date":327,"type":310},"2026-03-10",{"date":329,"type":310},"2027-12-31",{"name":5,"class":6},21]