[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542630":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":151,"collaborators":153,"id":168,"slug":25,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":25,"eligibilityCriteria":173,"healthyVolunteers":169,"sex":174,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":25,"studyType":180,"phases":181,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":91,"whyStopped":25,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Zhongnan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"mitoxantrone liposome, Ara-Cytarabine and azacitidine","EXPERIMENTAL","Mitoxantrone hydrochloride liposome 24 mg\u002Fm2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg\u002Fm2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;",[13],"Drug: mitoxantrone liposome, Ara-Cytarabine and azacitidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Daunorubicin, Ara-Cytarabine and azacitidine","ACTIVE_COMPARATOR","Daunorubicin 60 mg\u002Fm2, intravenously, once daily, days 1 to 3 Ara-Cytarabine 100 mg\u002Fm2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;",[19],"Drug: Daunorubicin,Ara-Cytarabine, azacitidine",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Mitoxantrone hydrochloride liposome 24 mg\u002Fm2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg\u002Fm2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Daunorubicin,Ara-Cytarabine, azacitidine","Daunorubicin 60 mg\u002Fm2, intravenously, once daily, days 1 to 3; Ara-Cytarabine 100 mg\u002Fm2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;",[15],[31],{"name":32,"affiliation":33,"role":34},"Fuling Zhou","Wuhan University","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Fuling Zhou, Doctor","CONTACT","027-67813137","zhoufuling@whu.edu.cn",[42,55,65,74,80,89,104,113,122,131,141],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"The First Affiliated Hospital of Zhengzhou University","NOT_YET_RECRUITING","Zhengzhou","Henan","450052","China",{"type":50,"coordinates":51},"Point",[52,53],113.64861,34.75778,{"lat":53,"lon":52},{"facility":56,"status":44,"city":57,"state":58,"zip":59,"country":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":25},"The Central Hospital of Huanggang","Huanggang","Hubei","438000",{"type":50,"coordinates":61},[62,63],114.87035,30.45143,{"lat":63,"lon":62},{"facility":66,"status":44,"city":67,"state":58,"zip":68,"country":48,"cosmosGeoPoint":69,"geoPoint":73,"contacts":25},"The First People's Hospital of Jingzhou","Jingzhou","434000",{"type":50,"coordinates":70},[71,72],112.19028,30.35028,{"lat":72,"lon":71},{"facility":75,"status":44,"city":67,"state":58,"zip":76,"country":48,"cosmosGeoPoint":77,"geoPoint":79,"contacts":25},"Jingzhou Central Hospital","434020",{"type":50,"coordinates":78},[71,72],{"lat":72,"lon":71},{"facility":81,"status":44,"city":82,"state":58,"zip":83,"country":48,"cosmosGeoPoint":84,"geoPoint":88,"contacts":25},"Shiyan Taihe Hospital","Shiyan","442000",{"type":50,"coordinates":85},[86,87],110.77806,32.6475,{"lat":87,"lon":86},{"facility":90,"status":91,"city":92,"state":58,"zip":93,"country":48,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Zhongnan Hospital of Wuhan University","RECRUITING","Wuhan","430071",{"type":50,"coordinates":95},[96,97],114.26667,30.58333,{"lat":97,"lon":96},[100],{"name":101,"role":38,"phone":102,"phoneExt":25,"email":103},"Zhou Fuling, director","+86-02767813137","zhoufuling@163.com",{"facility":105,"status":44,"city":106,"state":58,"zip":107,"country":48,"cosmosGeoPoint":108,"geoPoint":112,"contacts":25},"Xianning Central Hospital","Xianning","437100",{"type":50,"coordinates":109},[110,111],114.32201,29.84347,{"lat":111,"lon":110},{"facility":114,"status":44,"city":115,"state":58,"zip":116,"country":48,"cosmosGeoPoint":117,"geoPoint":121,"contacts":25},"The Central Hospital of Xiaogan","Xiaogan","432100",{"type":50,"coordinates":118},[119,120],113.92221,30.92689,{"lat":120,"lon":119},{"facility":123,"status":44,"city":124,"state":58,"zip":125,"country":48,"cosmosGeoPoint":126,"geoPoint":130,"contacts":25},"Yichang Central Hospital","Yichang","443003",{"type":50,"coordinates":127},[128,129],111.28472,30.71444,{"lat":129,"lon":128},{"facility":132,"status":44,"city":133,"state":134,"zip":135,"country":48,"cosmosGeoPoint":136,"geoPoint":140,"contacts":25},"Ruijin Hospital, Shanghai Jiaotong University School of Medicine","Wuxi","Jiangsu","214028",{"type":50,"coordinates":137},[138,139],120.28857,31.56887,{"lat":139,"lon":138},{"facility":142,"status":44,"city":143,"state":144,"zip":145,"country":48,"cosmosGeoPoint":146,"geoPoint":150,"contacts":25},"Shanxi Cancer Hospital","Taiyuan","Shanxi","030009",{"type":50,"coordinates":147},[148,149],112.56028,37.86944,{"lat":149,"lon":148},{"type":152,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[154,156,158,159,160,162,164,166,167],{"name":155,"class":6},"Ruijin Hospital",{"name":157,"class":6},"Shanxi Province Cancer Hospital",{"name":43,"class":6},{"name":75,"class":6},{"name":161,"class":6},"Yichang Central People's Hospital",{"name":163,"class":6},"Taihe Hospital",{"name":165,"class":6},"Central Hospital of Xiaogan",{"name":105,"class":6},{"name":66,"class":6},"100542630",false,"NCT06345365","MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)","A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;\n2. Age 18-75 years old;\n3. Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST\u002FALT \\\u003C2 × ULN, serum creatinine \\\u003C1.5 × ULN, 80 ml\u002Fmin ≤ creatinine clearance ≤120 ml\u002Fmin;\n4. Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \\\u003C1.5 × ULN;\n5. Physical condition: ECOG score 0-2;\n6. Obtained informed consent signed by the patient or family.\n\nExclusion Criteria:\n\n1. Allergy or significant contraindication to any of the drugs involved in the protocol;\n2. Patients with concomitant myelofibrosis;\n3. Severe cardiac disease, including myocardial infarction and cardiac insufficiency;\n4. Concomitant malignant tumours of other organs;\n5. Patients with active tuberculosis and HIV-positive patients;\n6. Other blood system diseases at the same time;\n7. Pregnant or breastfeeding women;\n8. Inability to understand or comply with the study protocol;\n9. Previous intolerance or allergy to similar drugs;\n10. Concurrent participation in other clinical studies;\n11. Any other condition that prevents the study from proceeding.","ALL","18 Years","75 Years",{"count":178,"type":179},154,"ESTIMATED","INTERVENTIONAL",[182],"PHASE3","Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine).",[185],"Acute Myeloid Leukaemia",[187,188,189,190],"Mitoxantrone liposome","Newly diagnosed AML patients","Ara-Cytarabine","Azacytidine","2024-04-09",{"date":193,"type":194},"2024-04-10","ACTUAL",{"date":196,"type":194},"2024-01-18",{"date":198,"type":179},"2028-12-31",{"name":5,"class":6},11]