myelodysplastic syndromes
Conditions
Interventions
Experimental group:Treatment
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Documented diagnosis of MDS less than 6 months according to WHO 2016 criteria that IPSS-R as being of very low, low, or intermediate risk. And blast is less than 5% in bone marrow; 2. Over 18 years old; 3. Subject has not previously been treated with ESA, luspatercept, lenalidomide or immunosuppressive therapy; 4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2; 5. Healthy liver and kidney function (creatinine= 30*10^9/L, absolute neutrophil count >= 0.5*10^9/L; 7. Understanding and complying with all experimental protocol requirements; 8. Subject could take medication orally. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Exclusion criteria
Exclusion criteria: 1. Plan to undergo chemotherapy during the study period or prior stem cell transplant; 2. Myelodysplastic syndrome with del (5q) ± 1 non 7 chromosome abnormality or complex karyotype; 3. Pregnant or breastfeeding females; 4. Patients who have received radiation therapy, immunotherapy, targeted therapy, biological therapy, chemotherapy, or any clinical research treatment within the first 14 days; 5. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for = 5 years; 6. Active infections that require systemic antibiotic treatment; 7. Expected life<6 months; 8. History of stroke, deep venous thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to treatment; 9. Currently requiring anticoagulant treatment; 10. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; 11. There is a serious heart disease, including New York Heart Association (NYHA) class IV congestive heart failure, or any other medical disease that the investigator believes may have an adverse effect on the subjects participating in the study; 12. Clinically significant or uncontrolled persistent inflammatory/autoimmune diseases (such as rheumatoid arthritis, Krohn's disease, ulcerative colitis, celiac disease, systemic lupus erythematosus, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin response rate of subjects during the treatment period (24 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin response rate of subjects during the treatment period (24 weeks);Time of first obtaining hemoglobin response;The incidence of transfusion during treatment;Proportion of subjects experiencing disease progression; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed