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