Myelodysplastic Syndrome
Conditions
Interventions
Phase II treatment group:Recombinant human erythropoietin: 10000 IU subcutaneous injection once a day
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) According to ipss-r, it was classified as extremely low-risk, low-risk or moderate risk, and the number of bone marrow primordial cells was less than 5%. 2) Aged 18-80 years, male or non pregnant, non lactating female. 3) The fertile female subjects and the 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) No treatment with ESA, tretinoin or androgen was received in the first 30 days. 5) ECOG score 0, 1 or 2. 6) The liver and kidney functions are sound (creatinine = 30 * 10^9 / L, neutrophil absolute count >= 0.5 * 10^9 / L. 8) Be able to follow the study visit schedule and understand and comply with all protocol requirements. 9) Can take medicine orally. Able and willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Myeloablative chemotherapy or whole brain and spinal radiotherapy are planned during the study period. 2) Hematopoietic stem cell transplantation (SCT) has been carried out in the past. 3) They were treated with G-CSF, thrombopoietin or thrombopoietin receptor agonist in the first 8 weeks. 4) In the first 12 weeks, the patients were treated with antithymocyte globulin, azacitidine, desetabine, cyclosporine, thalidomide or lenalidomide. 5) Receive any trial medication within 28 days before the first day. 6) 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) Active infection requiring systemic antibiotic treatment. 8) Life expectancy < 6 months. 9) History of epilepsy. 10) Thromboembolism events (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack [TIA]) occurred in the first 6 months. 11) Anticoagulant therapy is needed. 12) Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection is known. 13) Severe heart disease, including NYHA class III or IV congestive heart failure, uncontrolled hypertension or hypotension, or severe valve or endocardial disease, resulted in the risk of thromboembolism. 14) Clinically significant or uncontrolled persistent inflammatory / autoimmune diseases (such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, celiac disease, systemic lupus erythematosus, etc.). 15) Current abuse of alcohol and / or drugs. 16) 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, College of Medcine, Zhejiang University
Outcome results
None listed