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MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Sponsor: Zhongnan Hospital
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).
Official title: A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2024-01-18
Completion Date
2028-12-31
Last Updated
2024-04-10
Healthy Volunteers
No
Conditions
Interventions
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
Daunorubicin,Ara-Cytarabine, 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;
Locations (11)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Central Hospital of Huanggang
Huanggang, Hubei, China
The First People's Hospital of Jingzhou
Jingzhou, Hubei, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Shiyan Taihe Hospital
Shiyan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Xianning Central Hospital
Xianning, Hubei, China
The Central Hospital of Xiaogan
Xiaogan, Hubei, China
Yichang Central Hospital
Yichang, Hubei, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Wuxi, Jiangsu, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China