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NOT YET RECRUITING
NCT07486479
PHASE3

Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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

Interventions

DRUG

Mitoxantrone Hydrochloride Liposome

Mitoxantrone Hydrochloride Liposome: 24 mg/m², administered by intravenous drip (ivgtt) on day 1

DRUG

Venetoclax

Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po)

DRUG

Azacitidine

Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7

DRUG

Idarubicin

Idarubicin: 12 mg/m², administered by intravenous drip (ivgtt) on days 1-3

DRUG

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