Ciclosporin + Antithymocyte Immunoglobulin + Avatrombpag Versus Ciclosporin + Avatrombpag for the Treatment of Severe Aplastic Anemia in the Elderly

AVA-3

This is a multicenter, prospective, randonmized study. Our previous retrospective study showed that for SAA patients who were intolerant to ATG, CsA+ eltrombopag (EPAG) had similar efficacy to CsA+ATG+EPAG. Since the action mechanism of AVA and EPAG is not exactly the same, and the metabolic level of the elderly is not the same as that of younger patients, it is unknown whether there are predictive factors of efficacy in the treatment of AVA. We wondered whether CsA+AVA could achieve an efficacy similar to CsA+ATG+AVA in the Elderly. Meanwhile, to explore the predictive factors of efficacy, to find out a safe and effective treatment strategy for the Elderly.

2023-10-01

2025-10-01

2026-10-01

Not yet recruiting

Early phase I

60

Inclusion Criteria: 1. Patients with newly diagnosed severe aplastic anemia, aged greater than 60 years. 2. Patients met the diagnostic criteria of severe aplastic anemia (SAA). 3. Complete all screening assessments as outlined in the test protocol. 4. Without or with no more than 1 month treatment of ciclosporine, tacrolimus, glucocortocoid, or TPO-RAs. 5. Agree to sign the informed consent form. Exclusion Criteria: 1. Known diagnosis of congenital hematopoietic failure disorders (e.g. Fanconi anemia) and other causes of cytopenia. 2. Patients with uncontrolled bleeding and/or infection despite standard treatment. 3. Patients with previous history of hematopoietic stem cell transplantation. 4. Patients with previous history of thrombosis in 1 year. 5. Patients with concurrent malignancy. 6. Those who are considered unsuitable for enrollment by the investigator. 7. Abnormal renal function: creatinine \> 1.2 normal upper limit, albumin \< 0.9 normal lower limit, or CLcr \< 30 ml/min. 8. Abnormal liver function: transaminase \> 2.5 normal upper limit, or tota bilirubin \> 2.5 normal upper limit. 9. Patients with severe heart, liver or renal disease.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-08-18