Comparing cyclosporine and rituximab for treating autoimmune hemolytic anemia
Official title: Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Run by Assiut University · NCT05057468 · Data updated 2026-11-12
This study tests whether cyclosporine can be a better treatment than rituximab for adults with autoimmune hemolytic anemia who haven't improved with steroids.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Assiut University Academic / other |
| Drugs / interventions | rituximab |
| Locations | 2 sites (Asyut, Asyut Governorate and 1 other locations) |
| Status | Recruiting |
| Started | October 20, 2021 |
| Main results expected | November 1, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | March 20, 2025 |
| Trial ID | NCT05057468 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with primary warm autoimmune hemolytic anemia who have not responded to steroid therapy.
✕Probably not a fit
Patients with contraindications to the study drugs or those with secondary causes of autoimmune hemolytic anemia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of cyclosporine compared to rituximab in patients with primary autoimmune hemolytic anemia who have not responded to steroid treatment. The study focuses on adults over 18 years old with a confirmed diagnosis of the condition and aims to provide an alternative treatment option for those who are steroid-refractory or intolerant. By utilizing cyclosporine, which is known for its efficacy in immune cytopenic diseases and has a favorable safety profile, the trial seeks to address the limitations of current treatment protocols. The study is conducted at Assiut University Hospital in Egypt.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with steroid-refractory autoimmune hemolytic anemia.
How similar studies have gone: Previous studies have shown promising results for cyclosporine in similar immune-related conditions, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Assiut university hospital
Asyut, Asyut Governorate, Egypt Recruiting -
Assiut university hospital
Asyut, Asyut Governorate, Egypt Active not recruiting
Study contacts
- Study coordinator: ghada Abdallah
- Email: ghadaelsayed2008@yahoo.com
- Phone: +201008138002
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.