Acute myeloid leukemia
Conditions
Interventions
group 1:VAA regimen
Sponsors
the First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have histological evidence of AML, and the diagnosis results meet the World Health Organization classification of primary or secondary AML; 2. The subject is refractory or relapsed after receiving first-line AML treatment (with or without HSCT); 3. Age: >=18 years old to 70 years old; 4. Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0-2; 5. The expected survival period is more than 2 months; 6. No serious organic lesions in major organs (except renal insufficiency caused by this disease), and meet the requirements of the following laboratory test indicators (within 7 days before treatment): (1) Total bilirubin <= 1.5 times the upper limit of normal (for the same age group); (2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2 times the upper limit of normal (for the same age group); (3) Myocardial enzymes < 2 times the upper limit of normal (for the same age group); (4) The cardiac ejection fraction measured by echocardiography (ECHO) is within the normal range; 7. Men or women who are not pregnant, not breastfeeding, and may have children agree to use appropriate methods of contraception within 4 weeks before treatment, during treatment, during drug suspension and within 4 weeks after treatment; 8. Can provide informed consent, can understand and comply with the requirements of the research; 9. The subjects agree not to participate in other interventional studies during the treatment period; 10. The bone marrow routine shows that the degree of bone marrow proliferation is grade 3 and above.
Exclusion criteria
Exclusion criteria: 1. The subject has developed secondary AML after receiving chemotherapy for other tumors (except MDS) in the past; 2. The subject has been diagnosed with another malignancy, unless it has been disease-free for at least 5 years. Treatment-experienced subjects for non-melanoma skin cancer, carcinoma in situ, or cervical intraepithelial neoplasia (regardless of their disease-free survival) were eligible to participate in the study if they had completed curative treatment. Subjects with prostate cancer confined to the prostate and no evidence of disease recurrence or progression are eligible to participate in the study if they have started hormone therapy or have had surgery to remove the malignancy or have undergone radical radiation therapy; 3. Previous treatment with Venetoclax or other BCL-2 inhibitors or a history of severe hypersensitivity to azacitidine or cytarabine; 4. The subject has clinically significant coagulation abnormalities, such as disseminated intravascular coagulation; 5. Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases; 6. Subjects underwent major surgery within 4 weeks before the first dose of the study; 7. The subject has undergone radiotherapy within 4 weeks before the first dose of the study; 8. If the subject has New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or has a history of NYHA class 3 or 4 congestive heart failure, unless it was performed within 1 month prior to study entry Left ventricular ejection fraction (LVEF) >= 45% in echocardiography screening, otherwise they will not participate in the study; 9. The subject needs to use a strong inducer of cytochrome P450 (CYP) 3A in combination; 10. Subjects have ingested grapefruit, grapefruit products, limes (including jams containing limes) or star fruit within 3 days before starting study treatment; 11. The subject has malabsorption syndrome or other adverse conditions that hinder the intestinal route of administration; 12. The subject has evidence of other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) that require treatment; 13. The white blood cell count of the subject is >25 x 10^9/L (the use of hydroxyurea or leukocytosis is allowed to meet this standard); 14. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the study results; 15. Patients who are receiving other experimental drugs; 16. Pregnant or lactating women; 17. Those who cannot understand, follow the research protocol or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| minimal residual disease of leukemia;leukemia-free survival;Overall survival, OS;Duration of Response, DOR;progression-free survival;Safety; | — |
Countries
China
Contacts
Public ContactMeng Haitao
the First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed