Second-line Treatment of Primary Autoimmune Hemolytic Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclosporine, Rituximab.
- Who it may be relevant to
- Registry conditions: Primary Autoimmune Hemolytic Anemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Overview
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
- Drug Cyclosporine
2.5-5 mg orally for 3 months - Drug Rituximab
375 mg/ m2 weekly dose for a maximum of 4 weeks
Primary outcome measures
- the proportion of complete response [Time frame: 3months]
- the proportion of partial response [Time frame: 3months]
Secondary outcome measures (1)
- rate of adverse events [Time frame: 3months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Assiut university hospital — Asyut
- Assiut university hospital — Asyut
Identifiers
NCT: NCT05057468 · 17300534