Primary Autoimmune Hemolytic AnemiaPhase 3NCT05057468
Second-line Treatment of Primary Autoimmune Hemolytic Anemia
A Phase 3 study testing Cyclosporine and Rituximab in people with Primary Autoimmune Hemolytic Anemia, run by Assiut University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Autoimmune Hemolytic Anemia
- What is being tested?
- Cyclosporine and Rituximab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Oct 2021to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- any contraindications to the drugs of the study.
- any identified secondary cause of the AIHA.
- pregnant or lactating women.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 1 recruiting
- Active, not recruiting
Assiut university hospital
Asyut, Asyut Governorate, 17111
- Recruiting
Assiut university hospital
Asyut, Asyut Governorate
Mai Kamal, MD, +201223971678, mai_heamatology@aun.edu.eg
About this study
Official title: Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
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.
Read the 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.
- Conditions
- Primary Autoimmune Hemolytic Anemia
- Being tested
- Cyclosporine, Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
2.5-5 mg orally for 3 months
RituximabDrug
375 mg/ m2 weekly dose for a maximum of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine | Experimental | 2.5-5mg/kg of cyclosporine daily for 3 months Receives: Drug: Cyclosporine |
| Rituximab | Active comparator | 375 mg/ m2 weekly dose for a maximum of 4 weeks. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of complete response
Hb ≥12 g/dL and normalization of all hemolytic markers
Measured: 3months
the proportion of partial response
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
Measured: 3months
Secondary outcomes (1)
rate of adverse events
according to Common Terminology Criteria for Adverse Events Version 5
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start20 Oct 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada E. M. Abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057468
- Sponsor's protocol ID
- 17300534
- Status last verified
- Mar 2025
- First submitted
- 16 Sep 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT05057468
- Acronym / sponsor ID
- 17300534
- Conditions
- Primary Autoimmune Hemolytic Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine | Experimental | Drug: Cyclosporine2.5-5mg/kg of cyclosporine daily for 3 months |
| Rituximab | Active comparator | Drug: Rituximab375 mg/ m2 weekly dose for a maximum of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- any contraindications to the drugs of the study.
- any identified secondary cause of the AIHA.
- pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine2.5-5 mg orally for 3 months | Drug | Cyclosporine |
| Rituximab375 mg/ m2 weekly dose for a maximum of 4 weeks | Drug | Rituximab |
Primary outcome
the proportion of complete response
Time frame: 3months
Hb ≥12 g/dL and normalization of all hemolytic markers
the proportion of partial response
Time frame: 3months
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
1 secondary outcome
rate of adverse events
Time frame: 3months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclosporine and Rituximab in people with Primary Autoimmune Hemolytic Anemia, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ghada Abdallah (+201008138002, ghadaelsayed2008@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of complete response (time frame: 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.