Low to moderate risk myelodysplastic syndrome with thrombocytopenia
Conditions
Interventions
Experimental group:Hetrombopag Olamine Tablets combined with cyclosporine therapy
Sponsors
The First People's Hospital of Zhenjiang City
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: a. Myelodysplastic syndrome was diagnosed according to the 2016 WHO classification criteria and classified as very low, low, and intermediate risk according to the revised International Prognostic Scoring System (IPSS-R) score (=3.5). b. and bone marrow blasts 6 months; f. no treatment with platelet receptor agonists (TPO-RA, rhTPO) and IL-11 within one week before treatment; g. Complete liver and renal function (creatinine =1.5×ULN, BUN=1.5×ULN, ALT=2×ULN, AST=2×ULN, total bilirubin =1.5×ULN); h. Platelet count =30×109/L; i. Willing to sign the informed consent form, can understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Myelodysplastic syndrome with simple 5q- (5q- syndrome); 2.Patients previously treated with demethylated drugs; 3.Patients who had received TPO-RA for >=1 month prior to treatment; 4.Uncontrolled active infections and other active malignancies that may interfere with the study; 5.Have a New York Heart Society (NYHA) Class III or IV heart failure, uncontrolled high or low blood pressure, associated with thromboembolism risk or event; 6.Patients who have had an allergic reaction to the drugs used in this study or similar drugs; 7.There are any other circumstances in which the investigator considers the subject unsuitable for participation in 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 subjects with complete platelet response during the treatment period (24 weeks);Proportion of subjects with platelet response at week 24 of treatment;Incidence and severity of bleeding during treatment;Frequency of platelet transfusion during treatment;Platelet transfusion during treatment;Proportion of patients with disease progression;Proportion of subjects with red response * and neutrophil response * during the treatment period (24 weeks);The time of the first platelet response;The maximum duration of platelet response and the total number of days to achieve platelet response; | — |
Countries
China
Contacts
Public ContactJun Qian
The First People's Hospital of Zhenjiang City
Outcome results
None listed