Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Assiut University

Status and phase: Enrolling; Phase 3

Conditions: Primary Autoimmune Hemolytic Anemia

Treatments: Drug: Rituximab; Drug: Cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT05057468

17300534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cyclosporine

Experimental group

Description:

2.5-5mg/kg of cyclosporine daily for 3 months

Treatment:

Drug: Cyclosporine

Rituximab

Active Comparator group

Description:

375 mg/ m2 weekly dose for a maximum of 4 weeks.

Treatment:

Drug: Rituximab