Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cyclosporine as a Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Conditions
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Primary Autoimmune Hemolytic Anemia

Intervention / Treatment
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* Drug: Cyclosporine
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: any contraindications to the drugs of the study. any identified secondary cause of the AIHA. pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine<br>2.5-5mg/kg of cyclosporine daily for 3 months | Drug: Cyclosporine<br>* 2.5-5 mg orally for 3 months<br>|
| Active Comparator: Rituximab<br>375 mg/ m2 weekly dose for a maximum of 4 weeks. | Drug: Rituximab<br>* 375 mg/ m2 weekly dose for a maximum of 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of complete response | Hb ≥12 g/dL and normalization of all hemolytic markers | 3months | 
| the proportion of partial response | (Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of adverse events | according to Common Terminology Criteria for Adverse Events Version 5 | 3months |