Acute myeloid leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. AML diagnosed according to WHO diagnostic criteria; 2. AML patients with morphological leukemia-free status (MLFS) level or above after induction therapy with veneclax combined with azacitidine; 3. The subjects are 60 years old (including 60 years old) - 80 years old, regardless of gender or race; 4. Eastern Cooperative Oncology Group (ECOG) physical status <= 2; 5. Healthy liver and kidney function (creatinine<=3*ULN, BUN<=3*ULN, ALT<=3*ULN, AST<=3*ULN, total bilirubin<=3*ULN); 6. Able to comply with the study visit schedule, and understand and comply with all trial protocol requirements; 7. Can take medicine orally. Able and willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with acute promyelocytic leukemia (APL); 2. Patients with relapsed or refractory AML; 3. Receive any trial drug treatment within 28 days before the first day; 4. Any active malignancy, other than focal non-metastatic squamous cell or basal cell skin cancer or carcinoma in situ; patients with a history of malignancy but have been cured (eg, no evidence of malignancy for at least 2 years) can join the group; 5. There are other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) that require treatment; 6. There is a serious heart disease, including New York Heart Association (NYHA) class IV congestive heart failure, or any other medical disease that the investigator believes may have an adverse effect on the subjects participating in the study; 7. The subject has malabsorption syndrome or other adverse conditions that hinder the intestinal route of administration; 8. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; 9. Current alcohol and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable residual disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease free survival;Time to Progress; | — |
Countries
China
Contacts
The First Affiliated Hospital, College of Medicine, Zhejiang University