Venetoclax, Azacitidine and Liposomal Mitoxantrone Compared With Standard Chemotherapy for New AML
Compares two treatment combinations in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML
Key facts
- Where
- Changzhou, Hangzhou, Hefei, Huai'an, Jinan, Jingjiang, Lianyungang, Luoyang, Nanjing, Nantong, Ningbo, Suzhou, Wuhan, Wuxi, Yancheng, and Yangzhou, ChinaSee the 19 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with newly diagnosed acute myeloid leukemia (AML) who can have intensive chemotherapy. It compares two treatment combinations.
- Age
- 18 to 65 years
- Sex
- All genders can join.
- Disease stage
- Newly diagnosed AML (2022 WHO classification). Performance status ECOG 0 to 2. Life expectancy of at least 3 months.
- Earlier treatment
- No earlier anti-AML treatment (hydroxyurea or leukapheresis to control high white cell counts is allowed). No earlier hypomethylating agents or venetoclax.
- Biomarker or test result
- Liver and kidney tests must be adequate: for example ALT and AST ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL) or leukemia in the central nervous system
- AML that followed chemotherapy, radiotherapy or an earlier blood disorder
- Serious heart disease or heart rhythm problems
- HIV infection or active hepatitis B or C
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07486479, who can take part
Where in China
- Changzhou First People's HospitalChangzhou, ChinaNo longer taking part
- Zhejiang Cancer HospitalHangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaNo longer taking part
- Huai'an Second People's HospitalHuai'an, ChinaNo longer taking part
- Shandong First Medical University Affiliated Tumor HospitalJinan, ChinaNo longer taking part
- Jingjiang People's HospitalJingjiang, ChinaNo longer taking part
- The First People's Hospital of LianyungangLianyungang, ChinaNo longer taking part
- The Second People's Hospital of LianyungangLianyungang, ChinaNo longer taking part
- The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaNo longer taking part
- Jiangsu Province HospitalNanjing, ChinaNo longer taking part
- Jiangsu Province Hospital of Chinese MedicineNanjing, ChinaNo longer taking part
- Affiliated Hospital of Nantong UniversityNantong, ChinaNo longer taking part
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaNo longer taking part
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
- Renmin Hospital of Wuhan UniversityWuhan, ChinaNo longer taking part
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
- Wuxi People's HospitalWuxi, ChinaNo longer taking part
- Yancheng NO.1 People's HospitalYancheng, ChinaNo longer taking part
- Northern Jiangsu People's HospitalYangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07486479
- Record updated
- 20 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.