Chronic myelomonocytic leukemia
Conditions
Interventions
experimental group:venetoclax combined with azacytidine
Sponsors
The First Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. For subjects diagnosed with chronic monocytic leukemia according to WHO criteria, the score of the latest International prognostic score system (CPSS-mol) for chronic monocytic leukemia was > 2 (medium-risk -2, high-risk); 2. Subjects aged >=18 years, male or non-pregnant or non-lactating female; 3. Physical status score of the Eastern Oncology Consortium (ECOG) <=3; 4. Good liver and kidney function (creatinine <=3*ULN, BUN<=3*ULN, ALT<=3*ULN, AST<=3*ULN, total bilirubin <=3*ULN); 5. Able to follow the study visit schedule and understand and comply with all test protocol requirements; 6. Able to take medication orally, able and willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Received any experimental drug treatment within 28 days prior to enrollment; 2. 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 who have been cured (e.g., no evidence of malignancy for at least 2 years) can be enrolled; 3. There are other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) that require treatment; 4. Life expectancy <6 months; 5. Present with serious heart disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension or hypotensive disease, or severe valvular or endocardial disease, or a significant history of neurological, psychiatric, endocrine, metabolic, immune, liver, cardiovascular and cerebrovascular disease, or any other medical condition that the investigator believes may adversely affect the patient's participation in the study; 6. The patient has malabsorption syndrome or other adverse conditions that interfere with the intestinal route of drug administration; 7. Known human immunodeficiency virus (HIV), active hepatitis B or C infection; 8. Current abuse of alcohol and/or drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Overall survival;Incidence of disease progression; | — |
Countries
China
Contacts
Public ContactTong Hongyan
Outcome results
None listed