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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
2.5-5 mg orally for 3 months
375 mg/ m2 weekly dose for a maximum of 4 weeks
Assiut university hospital
Asyut, Asyut Governorate, Egypt
ACTIVE_NOT_RECRUITINGAssiut university hospital
Asyut, Asyut Governorate, Egypt
RECRUITINGthe proportion of complete response
Hb ≥12 g/dL and normalization of all hemolytic markers
Time frame: 3months
the proportion of partial response
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
Time frame: 3months
rate of adverse events
according to Common Terminology Criteria for Adverse Events Version 5
Time frame: 3months
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