Myelodysplastic Syndrome
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. For patients diagnosed with myelodysplastic syndrome according to WHO criteria, the score according to the revised International Prognostic Score System (IPSS-R) is > 3.5 (medium-risk, high-risk or very high-risk); 2. The subject must be >= 18 years, male or non-pregnant, non-lactating female; 3. Physical status of Eastern Cooperative Oncology Group (ECOG) <= 3; 4. The liver and kidney function were sound (creatinine <= 3 x ULN, BUN <= 3 x ULN, ALT <= 3 x ULN, AST <= 3 x ULN, total bilirubin <= 3 x ULN); 5. Compliance with the study visit schedule and understanding and compliance with all protocol requirements; 6. Oral medication. Ability and willingness to sign informed consent; 7. Total peripheral white blood cell (WBC) count <= 25,000 /µL (Note: Hydroxyurea therapy is allowed to reduce leukocytes to meet this inclusion criterion).
Exclusion criteria
Exclusion criteria: 1. Receive any trial drug within 28 days prior to the first day; 2. Any active malignancy, except focal non-metastatic squamous cell or basal cell skin cancer or carcinoma in situ; patients with a history of malignancy but who have been cured (e. g. no evidence of malignancy for at least 2 years) may be enrolled; 3. Presence of other clinically significant, poorly controlled systemic infections (viral, bacterial, or fungal) requiring treatment; 4. Life expectancy < 6 months; 5. Presence of severe heart disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension or hypotension, or severe valvular or endocardial disease, or a significant history of renal, neurological, psychiatric, endocrine, metabolic, immune, liver, cardiovascular and cerebrovascular diseases, or any other medical disease that the investigator believes may have an adverse effect on the subject's participation in the study; 6. The subject has malabsorption syndrome or other adverse conditions that hinder the intestinal route of administration; 7. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; 8. Current abuse of alcohol and/or drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed