myelodysplastic syndromes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Myelodysplastic syndrome diagnosed less than 6 months, classified as very low risk, low risk or intermediate risk 6 months; 5. No platelet receptor agonists (TPO-RA, rhTPO) and IL-11 treatment within one week before treatment; 6. Liver and kidney function is sound; 7. Platelet count <= 30 x 10^9/L; 8. Willing to sign an informed consent form, can understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Myelodysplastic syndrome with pure 5q-; 2. Patients previously treated with demethylating agents; 3. Patients treated with TPO-RAs for >= 1 month before treatment; 4. Active uncontrolled infection and other active malignancies that may interfere with the study; 5. Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled hypertension or hypotension, associated with thromboembolic risk, or events; 6. Patients with allergic reactions to drugs used in this study or similar drugs; 7. Any other condition that in the opinion of the investigator would make the subject inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with platelet response during the treatment period (24 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with disease progression;Overall survival;The incidence and severity of bleeding during treatment;Platelet transfusion frequency during treatment;Platelet transfusion volume during treatment;Proportion of patients with disease progression;Proportion of subjects with erythroid response and neutrophil response during the treatment period (24 weeks);Time of first occurrence of platelet response;Maximum duration of platelet response and total number of days of platelet response reaching the standard;Proportion of subjects with platelet >= 50×10^9 /L during the treatment period (24 weeks) ; | — |
Countries
China
Contacts
The First Affiliated Hospital of Zhejiang University Medical College