Acute myeloid leukemia
Conditions
Interventions
Group A:VMA therapy
Group B:Intensive therapy (IA or DA)
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients are fully aware of this study, voluntarily participate and sign an informed consent form (ICF) ; 2. Age >=18 years old, and =3 months; 7. Liver and kidney function: Alanine aminotransferase (ALT) and aspartic acid aminotransferase (AST) <=3 times the upper limit of normal value (ULN) (<=5 times the upper limit of normal value for patients with liver infiltration); total bilirubin <=1.5 times the upper limit of normal value (<=3 times the upper limit of normal value for patients with liver infiltration); serum creatinine <=1.5 times the upper limit of normal value;
Exclusion criteria
Exclusion criteria: 1. Meet any of the following conditions: a) Acute promyelocytic leukemia; b) Central nervous system leukemia; c) Myeloid sarcoma/granulocyte sarcoma; d) Those who have received past methylated drugs (HMA) or venecla treatment in the past; e) Previous medical history of MDS, CMML, MPN, and CML; 2. Subjects who have received other anti-AML treatments; 3. White blood cell count >=25×10^9/L before starting to receive research treatment (hydroxyurea, leukocyte isolation and small doses of cytarabine are allowed for whitening treatment, and the total dose of cytarabine does not exceed 1g) ; 4. Have suffered from other malignant tumors in the past 5 years (except for cured skin basal cell carcinoma, cervical carcinoma in situ and other malignant tumors that have not been treated and have been effectively controlled in the past 5 years) ; 5. Subjects who received a strong or moderate CYP3A inducer/inhibitor within 7 days before starting the study treatment; 6. Subjects with inability to take oral drugs or malabsorbent syndrome; 7. Heart function and disease meet one of the following conditions: a) Long QTc syndrome or QTc interval >480 ms; b) Complete left beam branch conduction block, degree II or III atrioventricular conduction block; c) Severe, uncontrolled arrhythmias that require medication; d) New York Society of Cardiology Grade >=Level II; e) Left ventricular ejection fraction (LVEF) is less than 50%; f) Within 6 months before admission, there is a history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia that requires treatment, a history of clinically serious pericardial disease, or there is evidence of ECG of acute ischemic or active conduction abnormalities. 8. Uncontrollable systemic diseases (such as active infections, uncontrollable hypertension, diabetes, etc.) ; 9. People infected with human immunodeficiency virus (HIV) (HIV antibody positive) ; 10. Active infection of hepatitis B and C (positive for hepatitis B surface antigen or core antibody, HBV-DNA is tested, and HBV-DNA exceeds 1x10^3 copy/mL is excluded; positive for hepatitis C antibody, HCV-RNA is tested, and HCV-RNA exceeds 1x10^3 copy/mL is excluded) ; 11. Have a known history of immediate or delayed hypersensitivity to similar drugs and excipients of the drug under study; 12. Accompanied by a history of severe nervous or mental illness; 13. Pregnant or lactating women; 14. The researchers judged that it was not suitable for patients to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compound remission rate after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Micro-residual disease to negative rate;Recurrence-free survival;Objective remission rate;Event-free lifetime; | — |
Countries
China
Contacts
Public ContactWeiwei Qin
The Second Affiliated Hospital of Fourth Military Medical University
Outcome results
None listed