Newly diagnosed patients with middle and high risk MDS and elderly AML
Conditions
Interventions
Intervention Group:Sitabenamide + azacytidine + venecola
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed medium-high risk MDS patients and elderly AML patients 2. Subjects are male or non-pregnant or non-lactating female; 3. Eastern Oncology Collaboration group (ECOG) physical status <= 3; 4. Healthy liver and kidney function (creatinine <= 3 x ULN, BUN <= 3 x ULN, ALT <= 3 x ULN, AST <= 3 x ULN, total bilirubin <= 3 x ULN); 5. Be able to adhere to the study visit schedule and understand and comply with all protocol requirements; 6. Able to take drugs orally, able and willing to sign informed consent; 7. For AML patients, peripheral blood total white blood cell (WBC) count <= 25,000 /µL (note: treatment with hydroxyurea is allowed to reduce WBC to meet this inclusion criteria).
Exclusion criteria
Exclusion criteria: 1. Receive any experimental drug within 28 days prior to the first day; 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 that has been cured (e.g., no evidence of malignancy for at least 2 years) can be enrolled; 3. The presence of other clinically significant systemic infections (viral, bacterial or fungal) that are poorly controlled and require treatment; 4. Life expectancy < 6 months; 5. The presence of serious heart disease, including NYHA class III or IV congestive heart failure, uncontrolled hypertension or hypotension, or severe valvular or endocardial disease, or significant history of kidney, nervous system, mental, endocrine, metabolic, immune, liver, cardio-cerebrovascular disease, Or any other medical condition that the investigator believes may adversely affect the subject's participation in the study; 6. Subjects have malabsorption syndrome or other adverse conditions that interfere with intestinal drug delivery pathway; 7. Known human immunodeficiency virus (HIV), hepatitis B or C infection; 8. Current alcohol and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Countries
China
Contacts
Public ContactMin zhang
Outcome results
None listed