ClinicalTrials.gov record NCT05057468
Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized Phase 3 study compares two second-line drug options—cyclosporine and rituximab—for adults with primary autoimmune hemolytic anemia who have had progression or failure on steroids or cannot/choose not to use standard steroid therapy. Participants are assigned to oral cyclosporine for three months or rituximab given weekly for up to four weeks. The main outcomes are complete and partial blood response at three months and the rate of adverse events. The study collects treatment and safety data to evaluate these outcomes.
What it is studying. The study compares cyclosporine versus rituximab as second-line treatments in adults with primary autoimmune hemolytic anemia by measuring complete and partial blood responses at three months and recording adverse events.
What the researchers hope to learn. To compare the proportion of complete and partial hematologic responses at three months between cyclosporine and rituximab, and to measure the rate of adverse events using CTCAE version 5.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Cyclosporine
- Rituximab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If enrolled, participants are randomly assigned to one of two drug treatments: cyclosporine taken daily (2.5–5 mg/kg) for 3 months, or rituximab given once weekly (375 mg/m2) for up to 4 weeks. Participants will have regular clinic visits and blood tests to check hemoglobin and markers of hemolysis, and to monitor for side effects; adverse events will be recorded. Response will be assessed at about 3 months. Other routine monitoring or visits required by the study protocol may occur as needed.
How the study is structured. Randomized, open-label Phase 3 drug trial with two parallel treatment groups. Adults are randomly assigned to receive either oral cyclosporine daily for three months or rituximab weekly for up to four weeks; responses and side effects are assessed with primary outcomes measured at three months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Oct 20, 2021
- Primary completion
- Nov 1, 2026 (estimated)
- Study completion
- Nov 30, 2026 (estimated)
- Target enrollment
- 30 participants (estimated)
- Last updated on registry
- Mar 20, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Assiut University
- Principal investigator
- Ghada E. M. Abdallah, lecturer in internal medicine department of faculty of medicine,Assiut university
Assiut University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- ghada Abdallah 📞 +201008138002 ✉ ghadaelsayed2008@yahoo.com
Participating sites (2)
- Assiut university hospitalActive Not Recruiting
Asyut, Asyut Governorate, 17111 · Egypt
- Assiut university hospitalRecruiting
Asyut, Asyut Governorate · Egypt
- Mai Kamal, MD · +201223971678 · mai_heamatology@aun.edu.eg
Terms used on this page · explanations by MedicalUpdates.ai
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- standard treatment
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- corticosteroid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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