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

Starting soon · Phase 3

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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.

Key facts

Study ID

NCT07486479

Run by

The First Affiliated Hospital of Soochow University

People needed

204

Starts

2026-03-10

Expected to finish

2027-12-31

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF).
• Aged 18 to 65 years, any gender. 3. Newly diagnosed with AML according to the 2022 WHO classification. 4. Eligible for intensive chemotherapy as determined by the investigator. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6. Life expectancy ≥ 3 months. 7. Adequate liver and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (≤ 5 × ULN for patients with hepatic involvement); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with hepatic involvement); serum creatinine ≤ 1.5 × ULN.

You may not qualify if…

• Patients who meet any of the following criteria will be excluded from the study:
• Any of the following conditions:
• Acute promyelocytic leukemia (APL);
• Central nervous system leukemia (CNSL);
• AML secondary to chemotherapy/radiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML);
• Prior treatment with hypomethylating agents (HMA) or venetoclax;
• Prior anti-AML therapy (except for leukocytosis management such as hydroxyurea or leukapheresis);
• History of other malignancies within the past 5 years (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies that have been effectively controlled without treatment in the past five years);
• Inability to take oral medication or malabsorption syndrome;
• Cardiac function or disease meeting any of the following criteria:
• Long QTc syndrome or QTc interval > 480 ms;
• Complete left bundle branch block, second- or third-degree atrioventricular block;
• Severe, uncontrolled arrhythmias requiring medication;
• New York Heart Association (NYHA) Class ≥ II;
• Left ventricular ejection fraction (LVEF) < 50%;
• History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other significant arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to enrollment, or ECG evidence of acute ischemia or active conduction system abnormalities.
• Uncontrolled systemic illnesses (e.g., active infection, uncontrolled hypertension, diabetes);
• Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
• Active Hepatitis B or C infection (Hepatitis B: HBsAg or HBcAb positive, with HBV-DNA > 1×10³ copies/mL; Hepatitis C: HCV-Ab positive, with HCV-RNA > 1×10³ copies/mL);
• Known history of immediate or delayed hypersensitivity reaction to drugs of the same class or excipients of the investigational product;
• Significant neurological or psychiatric history;
• Pregnant or lactating women;
• Patients considered by the investigator to be unsuitable for participation in this study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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