Acute myeloid leukemia
Conditions
Interventions
Testl group:Mitoxantrone hydrochloride liposome+Azacitidine+Venetoclax
Sponsors
Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients fully understand the study, voluntarily participate in it, and sign the Informed Consent Form (ICF); 2. Aged >= 18 years; 3. Clinically diagnosed with relapsed/refractory acute myeloid leukemia (non-APL, non-acute promyelocytic leukemia); 4. Normal cardiac function with a left ventricular ejection fraction (LVEF) >= 50%; 5. Hepatic and renal function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <= 2.5 times the upper limit of normal (ULN) (<= 5 times the ULN for patients with hepatic infiltration); total bilirubin <= 1.5 times the ULN; serum creatinine <= 1.5 times the ULN; 6. Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0-2.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions will be excluded from the study: 1. A history of other malignant tumors requiring treatment, or current concurrent malignant tumors requiring treatment; 2. Uncontrolled systemic diseases (e.g., progressive active infection, uncontrolled hypertension, etc.); 3. Diagnosis of central nervous system leukemia; 4. A known history of immediate or delayed hypersensitivity to drugs of the same class as the study drug or to its excipient components; 5. Pregnant women, lactating women, or patients who refuse to use effective contraceptive measures during the study period; 6. A history of severe neurological or psychiatric disorders; 7. Presence of other severe diseases such as myocardial infarction, severe or unstable angina pectoris, severe arrhythmia, cerebrovascular events (including transient ischemic attack), etc.; 8. Confirmed infection with human immunodeficiency virus (HIV); 9. Active hepatitis B or hepatitis C infection; 10. Other conditions deemed by the investigator to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission rate (CRc); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR);Overall survival (OS);Event-free survival (EFS);Safety; | — |
Countries
China
Contacts
Public ContactDengju Li
Huazhong University of Science Tongji Hospital, Tongji Medical College
Outcome results
None listed