Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05057468

Collaborator

(none)

Enrollment

Locations

Arms

13.3

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Autoimmune Hemolytic Anemia	Drug: Cyclosporine Drug: Rituximab	Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cyclosporine as a Second-line Treatment of Primary Autoimmune Hemolytic Anemia

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclosporine 2.5-5mg/kg of cyclosporine daily for 3 months	Drug: Cyclosporine 2.5-5 mg orally for 3 months
Active Comparator: Rituximab 375 mg/ m2 weekly dose for a maximum of 4 weeks.	Drug: Rituximab 375 mg/ m2 weekly dose for a maximum of 4 weeks

Arm

Intervention/Treatment

Experimental: Cyclosporine

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

Drug: Cyclosporine

2.5-5 mg orally for 3 months

Active Comparator: Rituximab

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

Drug: Rituximab

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

Outcome Measures

Primary Outcome Measures

the proportion of complete response [3months]
Hb ≥12 g/dL and normalization of all hemolytic markers
the proportion of partial response [3months]
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement

Secondary Outcome Measures

rate of adverse events [3months]
according to Common Terminology Criteria for Adverse Events Version 5

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.