Acute myeloid leukemia (MDS-drived)
Conditions
Interventions
Experimental group:VAA chemotherapy 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 myelodysplastic syndrome-transformed AML, and their diagnostic results meet the World Health Organization classification of primary or secondary AML (according to the 2016 WHO criteria); 2. Subjects with initial diagnosis who have not undergone chemotherapy; 3. Age: >=18 years old to 70 years old; 4. Eastern Cooperative Oncology Group (ECOG) physical performance status score of 0-2; 5. The expected survival period is more than 2 months; 6. The main organs have no serious organic lesions (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. Subjects who are not pregnant, not breastfeeding, and may have children agree to use appropriate methods of contraception 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 BCR-ABL positive leukemia (chronic myeloid leukemia blast phase); 2. The subject has secondary AML after receiving other tumor chemotherapy in the past; 3. The subject has active central nervous system leukemia; 4. Subject has been diagnosed with another malignancy unless he has been disease free for at least 5 years. Treatment-experienced subjects with 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 surgical resection of the malignancy or have undergone radical radiation therapy; 5. Previous treatment with Venetoclax or other BCL-2 inhibitors or a history of severe hypersensitivity to azacitidine or cytarabine; 6. The subject has clinically significant coagulation abnormalities, such as disseminated intravascular coagulation; 7. Subjects with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases; 8. The subject has undergone major surgery within 4 weeks before the first dose of the study; 9. The subject has undergone radiotherapy within 4 weeks before the first dose of the study; 10. If the subject has New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or has a previous history of NYHA class 3 or 4 congestive heart failure, not to participate in the study unless they have a left ventricular ejection fraction (LVEF) >= 45% on echocardiographic screening performed within 1 month prior to study entry; 11. The subject needs to use a strong inducer of cytochrome P450 (CYP) 3A in combination; 12. Subjects have ingested grapefruit, grapefruit products, limes (including jams containing limes) or star fruit within 3 days before starting the study treatment; 13. The subject has malabsorption syndrome or other adverse conditions that hinder the intestinal route of administration; 14. There is evidence of other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) requiring treatment; 15. The white blood cell count of the subject is >25 x 10^9/L (the use of hydroxyurea or leukapheresis is allowed to meet this standard); 16. 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; 17. Subjects who are receiving other experimental drugs; 18. Pregnant or lactating subjects; 19. 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;Overall survival;Duration of response;Progression-free survival;Safety; | — |
Countries
China
Contacts
Public ContactMeng Haitao
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed