A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of CsA+AVA in the Treatment of NSAA in the Elderly
Aplastic Anemia
About this trial
This is an interventional treatment trial for Aplastic Anemia
Eligibility Criteria
Inclusion Criteria: Elderly patients with well-defined NSAA anemia who meet the diagnostic criteria for aplastic anemia (AA) but do not meet the diagnostic criteria for severe aplastic anemia (SAA). AA is diagnosed if at least two of the following conditions are met: hemoglobin <100 g/L, platelet count <50×109/L, and neutrophil count <1.5×10^9/L. SAA diagnostic criteria: Meet the following diagnostic criteria, at least two of the following three criteria meet PLT < 20×10^9/L, ANC < 0.5×10^9/L, ARC < 60×10^9/L or red blood cell corrected volume <1%. Age 65 years or older, male or female. Subjects must complete all screening assessments listed in the trial protocol. Able to swallow or administer orally. Cannot tolerate or refuse ATG treatment. No previous treatment with cyclosporine, tacrolimus or hormones or treatment for less than 1 month. No TPO receptor agonists (including thrombopoietin, aitripopar, tritripopar, etc.) were used or TPO receptor agonists were used to treat the total dose of thrombopoietin, Eltrombopag, Herombopag, Avatrombopag and other TPO receptor agonists ≤1 week. Informed consent must be signed before the start of all specific research procedures. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent shall be signed by the patient's immediate family. Exclusion Criteria: Known congenital hematopoietic exhaustion diseases (such as Fanconi anemia) and other causes of pancytopenia and bone marrow hypoproliferative diseases (such as hemolytic PNH, hypoproliferative MDS/AML, autoantibody-mediated pancytopenia, etc.); Patients with uncontrolled bleeding and/or infection after standard treatment. Patients with a history of hematopoietic stem cell transplantation. History of high blood pressure. History of thrombosis. Patients with underlying cancer who also have malignant tumors or are receiving immunosuppressive therapy. Participants considered unsuitable for inclusion by the researchers. Renal function indicators: serum creatinine >1.2 times the upper limit of normal (ULN) or albumin <0.9 times the lower limit of normal (LLN); Patients with severe renal insufficiency with creatinine clearance <30ml/min; Liver function indicators: alanine aminotransferase (ALT) is 2.5 times higher than the upper limit of normal or AST is 2.5 times higher than the upper limit of normal or total bilirubin is 2.5 times higher than the upper limit of normal or serum creatinine is 1.5 times higher than the upper limit of normal; Serious heart, liver and kidney disease.
Sites / Locations
- Peking union medical college hospital
Arms of the Study
Arm 1
Experimental
treatment group
Cyclosporine: 3mg/kg/d orally divided into two times, the valley concentration of cyclosporine maintained at 100~150ng/ml, to achieve the maximum effect and began to reduce after 3 months, the reduction of 25mg every 3 months; Avatrombopag: The dosage was 40~60mg orally, once a day, and the dosage was adjusted according to the subject's platelet count. The drug was administered for 24 weeks (6 months).