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Clinical Trials in China / NCT07486479
Starting soon Phase 3

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

NCT07486479 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Soochow University
Phase
Phase 3
Started
2026-03-10
Last updated
2026-03-20

Condition(s) studied

Acute Myeloid Leukemia (AML)

Investigational drug(s) / intervention(s)

Mitoxantrone Hydrochloride LiposomeVenetoclaxAzacitidineIdarubicinCytarabine

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF). 2\. 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. Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from the study: 1. Any of the following conditions: 1. Acute promyelocytic leukemia (APL); 2. Central nervous system leukemia (CNSL); 3. AML secondary to chemotherapy/radiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML); 2. Prior treatment with hypomethylating agents (HMA) or venetoclax; 3. Prior anti-AML therapy (except for leukocytosis management such as hydroxyurea or leukapheresis); 4. 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); 5. Inability to take oral medication or malabsorption syndrome; 6. Cardiac function or disease meeting any of the following criteria: 1. Long QTc syndrome or QTc interval \> 480 ms; 2. Complete left bundle branch block, second- or third-degree atrioventricular block; 3. Severe, uncontrolled arrhythmias requiring medication; 4. New York Heart Association (NYHA) Class ≥ II; 5. Left ventricular ejection fraction (LVEF) \< 50%; 6. 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. 7. Uncontrolled systemic illnesses (e.g., active infection, uncontrolled hypertension, diabetes); 8. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive); 9. 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); 10. Known history of immediate or delayed hypersensitivity reaction to drugs of the same class or excipients of the investigational product; 11. Significant neurological or psychiatric history; 12. Pregnant or lactating women; 13. Patients considered by the investigator to be unsuitable for participation in this study.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Renmin Hospital of Wuhan University Wuhan Hubei
Changzhou First People's Hospital Changzhou Jiangsu
Huai'an Second People's Hospital Huai'an Jiangsu
Jingjiang People's Hospital Jingjiang Jiangsu
The First People's Hospital Of Lianyungang Lianyungang Jiangsu
The Second People's Hospital of Lianyungang Lianyungang Jiangsu
Jiangsu Province Hospital of Chinese Medicine Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
Affiliated Hospital of Nantong University Nantong Jiangsu
Affiliated Hospital of Nantong University Nantong Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
Wuxi People's Hospital Wuxi Jiangsu
YanCheng NO.1 People's Hospital Yancheng Jiangsu
Northern Jiangsu People's Hospital Yangzhou Jiangsu
Shandong First Medical University Affiliated Tumor Hospital Jinan Shandong
Zhejiang Cancer Hospital Hangzhou Zhejiang
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang

On this site

📄 Venclexta (venetoclax) drug profile →

More The First Affiliated Hospital of Soochow University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07486479 on ClinicalTrials.gov ↗ ← All trials in China