Myelodysplastic Syndrome
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to IPSS-R, the patients diagnosed as primary myelodysplastic syndrome were classified as extremely low-risk, low-risk or moderate risk, and the bone marrow primordial cells were less than 5%; 2. Aged from 18 to 80, male or non pregnant, non lactating female; 3. Fertile female subjects and fertile male subjects of their spouses must agree to use effective contraceptive methods during the trial and at least 3 months after the last administration of the study drug; 4. Patients who did not receive ESA, tretinoin or androgen treatment within 30 days before the first day; 5. Patients with ECoG score of 0, 1 or 2; 6. Patients with sound liver and kidney function (creatinine =30x10^9/L, neutrophil absolute count >=0.5x10^9/L; 8. Patients who are able to follow the study visit schedule and understand and comply with all protocol requirements; 9. Patients who can take medicine orally and who are willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who plan to undergo myeloablative chemotherapy or whole brain spinal cord radiotherapy during the study period; 2. Patients who have had hematopoietic stem cell transplantation (SCT) before; 3. Patients receiving granulocyte colony stimulating factor (G-CSF), thrombopoietin or thrombopoietin receptor agonist treatment within 8 weeks before the first day; 4. Patients who had received antithymocyte globulin, azacytidine, dessicabine, cyclosporine, thalidomide or lenalidomide treatment within 12 weeks before the first day; 5. Patients who received any trial drug treatment within 28 days before the first day; 6. Patients with any active malignant tumor, except for focal non metastatic squamous cell or basal cell skin cancer or carcinoma in situ; patients with a history of malignant tumor but cured (such as no evidence of malignant tumor for at least 5 years) can be included in the group; 7. Patients with active infection requiring systemic antibiotic treatment; 8. Patients with life expectancy < 6 months; 9. Patients with history of epilepsy; 10. Patients with thromboembolic events (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack [TIA]) within the first six months of the first day; 11. Patients who need anticoagulant treatment at present; 12. Patients with known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; 13. Patients with severe heart disease, including NYHA class III or IV congestive heart failure, uncontrolled hypertension or hypotension, or severe valve or endocardial disease, are at risk of thromboembolism; 14. Patients with clinically significant or uncontrolled persistent inflammatory / autoimmune diseases (such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, celiac disease, systemic lupus erythematosus, etc.); 15. Patients who are currently abusing alcohol and / or drugs; 16. Patients with a history of severe or active liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Time to first obtain hemoglobin response;Transfusion frequency; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed