Primary Autoimmune Hemolytic Anemia
Conditions
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.
Interventions
DRUGCyclosporine
2.5-5 mg orally for 3 months
DRUGRituximab
375 mg/ m2 weekly dose for a maximum of 4 weeks
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of complete response | 3months | Hb ≥12 g/dL and normalization of all hemolytic markers |
| the proportion of partial response | 3months | (Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of adverse events | 3months | according to Common Terminology Criteria for Adverse Events Version 5 |
Countries
Egypt
Contacts
Primary Contactghada Abdallah
Outcome results
None listed