acute myeloid leukemia (non-APL)
Conditions
Interventions
Group 1:HAV regimen
Group 2:Standard regimens
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years (inclusive); 2. Patients diagnosed with AML (non-APL) according to the WHO criteria (2016 edition), previously untreated except for hydroxyurea. Patients with AML include de novo AML, AML that has evolved from MDS or other AHD, and AML following prior cytotoxic therapy or radiation (secondary AML). Eligible patients with AML due to pre-existing blood disorders (AHD) including MDS may have been treated for pre-existing blood disorders (other than allograft). 3. ECOG score 0-2. 4. 7 days before randomization, the function of major organs is normal, that is, the following criteria are met: ALT and AST=50mL/min; LVEF measured by echocardiography>=45% (except for evaluation of leukemic organ involvement). 5. Male patients must agree to abstain from unprotected sex and sperm donation from the initial study drug administration until the end of the experiment or 90 days after withdrawal. Females of childbearing potential (ie, not menopausal or surgically sterilized for at least 1 year) must have a negative serum pregnancy test within 7 days prior to randomization. 6. In line with the requirements of the ethics committee, voluntarily signed the informed consent. 7. Able to comply with study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. The subject has central nervous system leukemia. 2. The subject tested positive for HIV. 3. The subject's cardiac function is New York Heart Association (NYHA) >= grade III. Class III is defined as asymptomatic at rest, but less than normal physical activity can cause excessive fatigue, palpitations, wheezing, or angina. 4. The subject has a significant history of renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease, or any other medical condition that the investigator believes that participation in this study will adversely affect him/her. 5. The subject exhibits evidence of other clinically significant uncontrolled conditions, including but not limited to: uncontrolled systemic infection. 6. Subjects have a history of other malignancies before entering the study, except for the following: (1) Adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; (2) Basal cell carcinoma of the skin or local squamous cell carcinoma of the skin; (3) The previous malignant tumor is limited to surgical resection (or treated in other ways), and the evaluation has been cured; (4) Malignant tumors that have been previously treated (surgery +/- chemotherapy +/- radiotherapy) and have no recurrence for at least two years after completion of treatment. 7. Subject's white blood cell count > 10 x 10^9/L (hydroxyurea can be used to meet the criteria). 8. The subject has received any form of chemotherapy, immunotherapy or study drug treatment other than hydroxyurea within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| biomarkers for efficacy prediction;optimal dose and concentration of Venetoclax; | — |
Countries
China
Contacts
Public ContactLuo Xiaohua
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed