eligibility_summary
Eligibility: Adults (>18) with newly diagnosed severe aplastic anemia (SAA) and platelet transfusion refractoriness (PTR). Exclusions: rituximab allergy, severe active infection, hypogammaglobulinemia, pregnancy or breastfeeding, NYHA class IV heart failure, uncontrolled neurologic/psychiatric illness impairing protocol adherence, chronic infections/diseases posing risk, or investigator deems unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Rituximab (100 mg weekly ×4) combined with cyclosporine (3–5 mg/kg/day). Mechanisms and drug types: Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes CD20+ B cells via antibody-dependent cellular cytotoxicity, complement activation, and apoptosis, aiming to remove platelet/HLA alloantibody-producing cells driving platelet transfusion refractoriness. Cyclosporine is a small-molecule calcineurin inhibitor that blocks T-cell activation by preventing NFAT-mediated IL-2 transcription, mitigating marrow-targeted autoimmunity in SAA. Targets/pathways: CD20+ B lymphocytes, humoral anti-platelet/HLA responses, T-cell receptor–calcineurin–NFAT–IL-2 signaling.