Second-line Treatment of Primary Autoimmune Hemolytic Anemia
- Conditions
- Primary Autoimmune Hemolytic Anemia
- Interventions
- Registration Number
- NCT05057468
- Lead Sponsor
- Assiut University
- Brief Summary
the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This study compares cyclosporin versus rituximab in steroid-refractory anemia.
- Detailed Description
Auto-immune hemolytic anemia (AIHA) is a heterogeneous syndrome in adults. This disease is associated with significant morbidity-mortality. First-line treatment with prolonged corticosteroid is well identified but there is not enough data about cyclosporine treatment in case of resistance or dependence on steroids.
the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This drug is cheap, licensed in immunologic diseases, and does not expose to major infections. So, we compare cyclosporin versus rituximab in steroid-refractory anemia.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Patients aged more than 18 years old from any sex with a diagnosis of primary warm autoimmune hemolytic anemia (AIHA) based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test who have disease progression or failure after treatment with steroid therapy, or who are intolerant to treatment, or who refuse standard treatment.
- No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.
- any contraindications to the drugs of the study.
- any identified secondary cause of the AIHA.
- pregnant or lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab Rituximab 375 mg/ m2 weekly dose for a maximum of 4 weeks. Cyclosporine Cyclosporine 2.5-5mg/kg of cyclosporine daily for 3 months
- Primary Outcome Measures
Name Time Method the proportion of partial response 3months (Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
the proportion of complete response 3months Hb ≥12 g/dL and normalization of all hemolytic markers
- Secondary Outcome Measures
Name Time Method rate of adverse events 3months according to Common Terminology Criteria for Adverse Events Version 5
Trial Locations
- Locations (1)
Assiut university hospital
🇪🇬Assiut, Egypt