A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;
• Age 18-75 years old;
• Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST/ALT \<2 × ULN, serum creatinine \<1.5 × ULN, 80 ml/min ≤ creatinine clearance ≤120 ml/min;
• Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × ULN;
• Physical condition: ECOG score 0-2;
• Obtained informed consent signed by the patient or family.
Locations
Other Locations
China
The Central Hospital of Huanggang
NOT_YET_RECRUITING
Huanggang
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
The First People's Hospital of Jingzhou
NOT_YET_RECRUITING
Jingzhou
Shiyan Taihe Hospital
NOT_YET_RECRUITING
Shiyan
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Wuxi
Xianning Central Hospital
NOT_YET_RECRUITING
Xianning
The Central Hospital of Xiaogan
NOT_YET_RECRUITING
Xiaogan
Yichang Central Hospital
NOT_YET_RECRUITING
Yichang
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Fuling Zhou, Doctor
zhoufuling@whu.edu.cn
027-67813137
Time Frame
Start Date:2024-01-18
Estimated Completion Date:2028-12-31
Participants
Target number of participants:154
Treatments
Experimental: mitoxantrone liposome, Ara-Cytarabine and azacitidine
Mitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;
Active_comparator: Daunorubicin, Ara-Cytarabine and azacitidine
Daunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3 Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;
Collaborators: Xianning Central Hospital, Shanxi Province Cancer Hospital, Jingzhou Central Hospital, The First Affiliated Hospital of Zhengzhou University, Ruijin Hospital, The First People's Hospital of Jingzhou, Taihe Hospital, Yichang Central People's Hospital, Central Hospital of Xiaogan