nctId: NCT06345365 id: 09 briefTitle: MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) overallStatus: RECRUITING date: 2024-01-18 date: 2026-12-31 date: 2028-12-31 date: 2024-04-03 date: 2024-04-10 name: Zhongnan Hospital class: OTHER name: Ruijin Hospital name: Shanxi Province Cancer Hospital name: The First Affiliated Hospital of Zhengzhou University name: Jingzhou Central Hospital name: Yichang Central People's Hospital name: Taihe Hospital name: The Central Hospital of Xiaogan name: Xianning Central Hospital name: The First People's Hospital of Jingzhou briefSummary: 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). conditions: Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: mitoxantrone liposome, Ara-Cytarabine and azacitidine name: Daunorubicin,Ara-Cytarabine, azacitidine measure: Complete remission rate measure: Incidence of adverse events measure: Compound CR rate measure: Objective remission rate measure: No remission rate measure: Event-free survival measure: Disease-free survival measure: Overall survival measure: Mortality rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China lat: 34.75778 lon: 113.64861 facility: The Central Hospital of Huanggang status: NOT_YET_RECRUITING city: Huanggang state: Hubei zip: 438000 country: China lat: 23.67704 lon: 116.99961 facility: The First People's Hospital of Jingzhou status: NOT_YET_RECRUITING city: Jingzhou state: Hubei zip: 434000 country: China lat: 30.35028 lon: 112.19028 facility: Jingzhou Central Hospital status: NOT_YET_RECRUITING city: Jingzhou state: Hubei zip: 434020 country: China lat: 30.35028 lon: 112.19028 facility: Shiyan Taihe Hospital status: NOT_YET_RECRUITING city: Shiyan state: Hubei zip: 442000 country: China lat: 32.6475 lon: 110.77806 facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Zhou Fuling, director role: CONTACT phone: +86-02767813137 email: zhoufuling@163.com lat: 30.58333 lon: 114.26667 facility: Xianning Central Hospital status: NOT_YET_RECRUITING city: Xianning state: Hubei zip: 437100 country: China lat: 29.84347 lon: 114.32201 facility: The Central Hospital of Xiaogan status: NOT_YET_RECRUITING city: Xiaogan state: Hubei zip: 432100 country: China lat: 30.92689 lon: 113.92221 facility: Yichang Central Hospital status: NOT_YET_RECRUITING city: Yichang state: Hubei zip: 443003 country: China lat: 30.71444 lon: 111.28472 facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214028 country: China lat: 31.56887 lon: 120.28857 facility: Shanxi Cancer Hospital status: NOT_YET_RECRUITING city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 hasResults: False