[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542630":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":152,"collaborators":154,"id":169,"slug":170,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":25,"eligibilityCriteria":175,"healthyVolunteers":171,"sex":176,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":25,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":92,"whyStopped":25,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"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",[42,56,66,75,81,90,105,114,123,132,142],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":25},"The First Affiliated Hospital of Zhengzhou University","NOT_YET_RECRUITING","Zhengzhou","Henan","450052","China","CN",{"type":51,"coordinates":52},"Point",[53,54],113.64861,34.75778,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":59,"zip":60,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"The Central Hospital of Huanggang","Huanggang","Hubei","438000",{"type":51,"coordinates":62},[63,64],114.87035,30.45143,{"lat":64,"lon":63},{"facility":67,"status":44,"city":68,"state":59,"zip":69,"country":48,"countryCode":49,"cosmosGeoPoint":70,"geoPoint":74,"contacts":25},"The First People's Hospital of Jingzhou","Jingzhou","434000",{"type":51,"coordinates":71},[72,73],112.19028,30.35028,{"lat":73,"lon":72},{"facility":76,"status":44,"city":68,"state":59,"zip":77,"country":48,"countryCode":49,"cosmosGeoPoint":78,"geoPoint":80,"contacts":25},"Jingzhou Central Hospital","434020",{"type":51,"coordinates":79},[72,73],{"lat":73,"lon":72},{"facility":82,"status":44,"city":83,"state":59,"zip":84,"country":48,"countryCode":49,"cosmosGeoPoint":85,"geoPoint":89,"contacts":25},"Shiyan Taihe Hospital","Shiyan","442000",{"type":51,"coordinates":86},[87,88],110.77806,32.6475,{"lat":88,"lon":87},{"facility":91,"status":92,"city":93,"state":59,"zip":94,"country":48,"countryCode":49,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Zhongnan Hospital of Wuhan University","RECRUITING","Wuhan","430071",{"type":51,"coordinates":96},[97,98],114.26667,30.58333,{"lat":98,"lon":97},[101],{"name":102,"role":38,"phone":103,"phoneExt":25,"email":104},"Zhou Fuling, director","+86-02767813137","zhoufuling@163.com",{"facility":106,"status":44,"city":107,"state":59,"zip":108,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":25},"Xianning Central Hospital","Xianning","437100",{"type":51,"coordinates":110},[111,112],114.32201,29.84347,{"lat":112,"lon":111},{"facility":115,"status":44,"city":116,"state":59,"zip":117,"country":48,"countryCode":49,"cosmosGeoPoint":118,"geoPoint":122,"contacts":25},"The Central Hospital of Xiaogan","Xiaogan","432100",{"type":51,"coordinates":119},[120,121],113.92221,30.92689,{"lat":121,"lon":120},{"facility":124,"status":44,"city":125,"state":59,"zip":126,"country":48,"countryCode":49,"cosmosGeoPoint":127,"geoPoint":131,"contacts":25},"Yichang Central Hospital","Yichang","443003",{"type":51,"coordinates":128},[129,130],111.28472,30.71444,{"lat":130,"lon":129},{"facility":133,"status":44,"city":134,"state":135,"zip":136,"country":48,"countryCode":49,"cosmosGeoPoint":137,"geoPoint":141,"contacts":25},"Ruijin Hospital, Shanghai Jiaotong University School of Medicine","Wuxi","Jiangsu","214028",{"type":51,"coordinates":138},[139,140],120.28857,31.56887,{"lat":140,"lon":139},{"facility":143,"status":44,"city":144,"state":145,"zip":146,"country":48,"countryCode":49,"cosmosGeoPoint":147,"geoPoint":151,"contacts":25},"Shanxi Cancer Hospital","Taiyuan","Shanxi","030009",{"type":51,"coordinates":148},[149,150],112.56028,37.86944,{"lat":150,"lon":149},{"type":153,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[155,157,159,160,161,163,165,167,168],{"name":156,"class":6},"Ruijin Hospital",{"name":158,"class":6},"Shanxi Province Cancer Hospital",{"name":43,"class":6},{"name":76,"class":6},{"name":162,"class":6},"Yichang Central People's Hospital",{"name":164,"class":6},"Taihe Hospital",{"name":166,"class":6},"Central Hospital of Xiaogan",{"name":106,"class":6},{"name":67,"class":6},"100542630","phase-3-maaza-regimen-for-the-treatment-of-newly-diagnosed-acute-myeloid-leukemia-aml-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":180,"type":181},154,"ESTIMATED","INTERVENTIONAL",[184],"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).",[187],"Acute Myeloid Leukaemia",[189,190,191,192],"Mitoxantrone liposome","Newly diagnosed AML patients","Ara-Cytarabine","Azacytidine","2024-04-09",{"date":195,"type":196},"2024-04-10","ACTUAL",{"date":198,"type":196},"2024-01-18",{"date":200,"type":181},"2028-12-31",{"name":5,"class":6},11]