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A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
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).
In this study, AML patients were randomly divided into MA+AZA treatment group and DA+AZA treatment group by conducting a prospective, multicentre, exploratory, randomised controlled study. By observing the efficacy and safety of the MA+AZA combination regimen in the treatment of primary AML, and comparing the superiority of the traditional regimen, high-quality clinical evidence was obtained, providing practical evidence to support the improvement of the intervention effect and clinical prognosis of primary AML.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 18, 2024
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2028
Last Updated
April 10, 2024
154
ESTIMATED participants
mitoxantrone liposome, Ara-Cytarabine and azacitidine
DRUG
Daunorubicin,Ara-Cytarabine, azacitidine
DRUG
Lead Sponsor
Zhongnan Hospital
Collaborators
NCT07148180
NCT05534620
Data Source & Attribution
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