Mixed Phenotype Acute Leukemia
Conditions
Interventions
Treatment group:Mitoxantrone Hydrochloride Liposome Injection Combined with Cytarabine, Etoposide, Dexamethasone +/- Venetoclax
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF); 2 Age: 14-75 years old; 3 The mixed phenotype leukemia diagnosed clinically meets the 2016 WHO diagnostic criteria (when urgent)The molecular marker scores of B, T, and myeloid cell lines in the immune scoring system for leukemia, any one of whichWhen the score of molecular markers in one cell line is 2 points, those with scores of molecular markers in other cell lines >= 1 point are Can be included; 4 Normal heart function, heart ejection fraction > 50%; 5 Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase(AST) <= 2.5 times the upper limit of normal (ULN) (<= 5 times the normal value for patients with liver infiltration) Limit); Total bilirubin <= 1.5 times the upper limit of normal value; Serum creatinine <= 1.5 times the upper limit of normal value; 6 Eastern Oncology Collaboration Group (ECOG) Physical Status Score: 0-2 points
Exclusion criteria
Exclusion criteria: 1 Individuals who have previously or currently suffered from other malignant tumors and require treatment; 2 Uncontrollable systemic diseases (such as prolonged active infections, uncontrolled hypertension, etc.); 3 Suffering from central nervous system leukemia; 4 There is a known history of immediate or delayed hypersensitivity reactions to similar drugs and excipient components of the investigational drug; 5 Pregnant women, lactating women, and patients who refuse to take effective contraceptive measures during the study period; 6 Accompanied by severe neurological or psychiatric history; 7 Other serious illnesses such as myocardial infarction, severe or unstable angina, and severe arrhythmia 8 Known to be infected with human immunodeficiency virus (HIV); Active infection of hepatitis B and C; Non active hepatitis carriers or subjects with low viral hepatitis virus titers after treatment with non prohibited antiviral drugs are not excluded. 9 Patients with inability to take oral medication or malabsorption syndrome. 10 Researchers have determined that there are patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission rate(CRc); | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal residual disease (MRD) negative rate;Evenr-free survival(EFS);Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactYaohui Wu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed