Leukemia
Conditions
Interventions
Experimental group:Azacitidine ± Venetoclax
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. No gender limit, aged >=18 years; 2. The patient was diagnosed as acute myeloid leukemia (non-M3) according to WHO criteria, and the disease risk included low risk, medium risk and high risk; 3. CR/CRi >=2 courses of consolidation therapy; 4. Patients with no donor or unsuitable for transplantation; 5. Flow residual negative and gene positive; 6. Able to understand and voluntarily sign written informed consent, which must be signed prior to the execution of any procedure specified in the test; 7.ECOG score 1.5x ULN, 24-hour creatinine clearance >=50mL/min (using the Cockcroft-Gault formula, see Annex 3); (2) Serum albumin >= 3.0 g/dL; (3) Serum total bilirubin 50%, pulmonary artery systolic blood pressure <=50mmHg; 9. Patients must be willing and able to complete study procedures and follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. Malabsorption syndrome or other diseases affecting the absorption of oral drugs. 2. Patients who have received autologous or allogeneic hematopoietic stem cell transplantation. 3. Active central nervous system (CNS) diseases confirmed by cytology or pathology; A lumbar puncture is not necessary in the absence of CNS disease. 4. Patients diagnosed with another malignancy (patients who have been cured for >=5 years, or non-melanoma skin cancer that has been completely resected, carcinoma in situ that has been successfully treated, or prostate cancer that has been controlled, can be included in this study if the researchers judge that it will not affect the efficacy and safety evaluation of this study). 5. An active symptomatic infection. 6. Patients with known allergy to study drug ingredients or their analogues. 7. Patients with blood ß-HCG positive, pregnant or lactating women, or patients expecting to become pregnant during the study plan. 8. Any symptoms or diseases of the patient may, in the judgment of the investigator or sponsor, affect the safety of the patient or interfere with the evaluation of the efficacy and safety of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJiang Qian
Outcome results
None listed