transfusion dependent non-severe aplastic anemia,TD-NSAA
Conditions
Interventions
Test Group:Cyclosporine Combined with Romiplostim N01
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Peripheral blood and bone marrow examination results meet the diagnostic criteria for TD-NSAA; 2. Age >=18 years; 3. The subject or their legal guardian voluntarily signs the informed consent form, understands the nature, purpose, and procedures of this trial, and is willing to comply with the trial requirements.
Exclusion criteria
Exclusion criteria: 1. Bone marrow fibrosis grade >=2; 2. Previous treatment with anti-human thymocyte immunoglobulin (ATG); 3. Previous allogeneic hematopoietic stem cell transplantation; 4. Discontinuation of other TPO-R agonists for less than 5 half-lives; 5. Active malignancy (except localized tumors with curative resection >1 year prior); 6. Clinically significant cardiac disease (NYHA class III–IV), unstable angina, myocardial infarction within 6 months, cardiac revascularization/stenting within 6 months, clinically significant arrhythmias, or uncontrolled hypertension; 7. History of arterial/venous thrombosis within 1 year; 8. Positive anti-HIV, HBsAg, or HCV-RNA; 9. Other causes of thrombocytopenia (e.g., MDS, ITP, cirrhosis); 10. High-activity PNH (LDH >1.5×ULN); 11. Active uncontrolled infection; 12. Uncontrolled diabetes mellitus; 13. ECOG performance status >2; 14. AST or ALT >3×ULN; 15. Serum creatinine >=2.5×ULN; 16. Pregnant or lactating women; 17. Investigator-determined unsuitability or inability to comply with trial requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;12-month overall response rate;event-free survival;MDS/AML transformation rate;Time to achieve response;Bone marrow fibrosis grade;Platelet transfusion independence rate;Adverse events; | — |
Countries
China
Contacts
Public ContactGuangsheng He
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed