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Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML
Sponsor: The First Affiliated Hospital of Soochow University
Summary
This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study of Venetoclax Combined With Azacitidine and Mitoxantrone Hydrochloride Liposome Versus Idarubicin Combined With Cytarabine "3+7" in the Treatment of Newly Diagnosed AML
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2026-03-10
Completion Date
2027-12-31
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Mitoxantrone Hydrochloride Liposome
Mitoxantrone Hydrochloride Liposome: 24 mg/m², administered by intravenous drip (ivgtt) on day 1
Venetoclax
Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po)
Azacitidine
Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7
Idarubicin
Idarubicin: 12 mg/m², administered by intravenous drip (ivgtt) on days 1-3
Cytarabine
Cytarabine: 100 mg/m², administered by intravenous drip (ivgtt) on days 1-7
Locations (21)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
Jingjiang People's Hospital
Jingjiang, Jiangsu, China
The First People's Hospital Of Lianyungang
Lianyungang, Jiangsu, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
YanCheng NO.1 People's Hospital
Yancheng, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China