Myelodysplastic Syndrome
Conditions
Interventions
Control group:CsA
Experimental group:CsA+Epag
Sponsors
The Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
17 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. PTs confirmed by hematology, bone marrow smear and biopsy histopathology and cytogenetics and molecular testing in accordance with the 2016 vienna MDS minimum diagnostic criteria; 2. Lower risk according to MDS international prognostic score system (IPSS):0; medium risk-1(INT-1):0.5~1 and very low risk group in revised edition of international prognostic score system (IPSS-R):1.5, low risk group :1.5~3, medium risk group :3~4.5. 3. unsuitable or unwilling to undergo hematopoietic stem cell transplantation (HSCT); 4. aged between 17 and 70 years; 5. General status of eastern United States tumor tissue ECOG score 0-3 and survival is expected to be more than 3 months; 6. The subjects developed persistent symptomatic anemia (hemoglobin 15 HIV, HBV and HCV negative (HBV of which HBV-DNA negative) 8. Understand research procedures and voluntarily comply with research programs, follow-up plans, laboratory and auxiliary examinations.
Exclusion criteria
Exclusion criteria: 1. Percetage of Bone marrow blast cells >5%; 2. Bone marrow biopsy combined with bone marrow fibrosis, including net silver staining Grade 3 and above; 3. ATG,CsA macrophenate, sirolimus, etanercept,alemtuzumab were used for immunosuppressive therapy before entering the group, or other TPO-RA were used in the month before entering the group (e.g., romistine, human recombinant TPO, etc); 4. Previous history of hematopoietic stem cell transplantation; 5. Any active infection includes severe uncontrolled bacterial, mycobacterial, fungal, and viral infections such as herpes zoster virus (HZV); 6. For subjects, any drug and drug excipients in the program are allergic or contraindicated; 7. Significant organ dysfunction: such as respiratory failure, New York Heart Association NYHA grade >=grade 2 chronic congestive heart failure, prolonged QT interval, decompensated liver or kidney dysfunction, high blood pressure (>180/100 mmHg), is still beyond control despite active treatment, and hyperlipidemia; 8. Active thrombosis, nearly 12 months have cardiovascular and cerebrovascular thrombotic events; 9. Other tumors that have not yet been cured/or are uncertain within 5 years; 10. Other experimental drugs are being used; 11. Pregnancy or lactation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PFS;EFS;OS;TTP;DOR; | — |
Primary
| Measure | Time frame |
|---|---|
| CR;PR;SD;HI-E;HI-P;TI; | — |
Countries
China
Contacts
Public ContactChunkang CHANG
The Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Outcome results
None listed