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)
Composite Complete Remission(CRc) rate after one cycle of induction therapy — At the end of the first treatment cycle (Day 28 ± 7), each cycle is 28 days). Complete remission plus complete remission with partial hematologic recovery plus complete remission with incomplete hematologic recovery (CR+CRh+CRi). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.
Trial sites (21)
Facility
City
Region
Status
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
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.
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