Myelodysplastic Syndrome
Conditions
Interventions
experimental group:Recombinant human erythropoietin, 36000IU subcutaneous injection biw
ATRA, 20mg po bid
testosterone undecanoate, 80mg po bid
Continuous administration of the three drugs for 12 weeks.
control group:Recombinant human erythropoietin, 36000IU subcutaneous injection biw
Placebo, 20mg po bid
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. Primary myelodysplastic syndrome diagnosed less than 6 months is classified as very low-risk, low-risk or intermediate-risk =30×10^9/L, absolute neutrophil count >=0.5×10^9/L; 6. Serum erythropoietin level > 500IU/L; 7. Willing to sign the informed consent form, understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Planned myeloablative chemotherapy or craniospinal radiotherapy during the study period, or prior history of hematopoietic stem cell transplantation (SCT); 2.Myelodysplastic syndromes with isolated del(5q) (5q- syndrome); 3.Prior treatment with hypomethylating agents, lenalidomide, or luspatercept; 4.Previous failure of high-dose erythropoietin (EPO) therapy after a continuous 12-week treatment course; 5.Uncontrolled active infection, or other active malignancies that may interfere with the study; 6.New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled hypertension or hypotension, or conditions with risk of thromboembolic events; 7.Thromboembolic events within 6 months prior to enrollment (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, or transient ischemic attack [TIA]), or patients deemed inappropriate for this clinical trial by the investigator; 8.Any other condition considered by the investigator to render the patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin response rate of subjects during the treatment period (12 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in red blood cell transfusion volume during treatment;Proportion of subjects achieving transfusion independence during the treatment period;Time to First Hemoglobin Response;Duration of Hemoglobin Response;Correlation between IPSS-R/M prognostic stratification, prior treatment status, and hemoglobin response rate;Overall survival;Platelet response rate and neutrophil response rate at 2 weeks after the end of the treatment period;Proportion of subjects with disease progression from baseline to week 20; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The First Affiliated Hospital, College of Medcine, Zhejiang University
Outcome results
None listed