Back to resultsSecond-line Treatment of Primary Autoimmune Hemolytic Anemia
Primary Purpose
Primary Autoimmune Hemolytic Anemia
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Cyclosporine
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Primary Autoimmune Hemolytic Anemia
Eligibility 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.
Sites / Locations
- Assiut university hospital
- Assiut university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cyclosporine
Rituximab
Arm Description
2.5-5mg/kg of cyclosporine daily for 3 months
375 mg/ m2 weekly dose for a maximum of 4 weeks.
Outcomes
Primary Outcome Measures
the proportion of complete response
Hb ≥12 g/dL and normalization of all hemolytic markers
the proportion of partial response
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
Secondary Outcome Measures
rate of adverse events
according to Common Terminology Criteria for Adverse Events Version 5
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05057468
Brief Title
Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Official Title
Cyclosporine as a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Autoimmune Hemolytic Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyclosporine
Arm Type
Experimental
Arm Description
2.5-5mg/kg of cyclosporine daily for 3 months
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
375 mg/ m2 weekly dose for a maximum of 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
2.5-5 mg orally for 3 months
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/ m2 weekly dose for a maximum of 4 weeks
Primary Outcome Measure Information:
Title
the proportion of complete response
Description
Hb ≥12 g/dL and normalization of all hemolytic markers
Time Frame
3months
Title
the proportion of partial response
Description
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
Time Frame
3months
Secondary Outcome Measure Information:
Title
rate of adverse events
Description
according to Common Terminology Criteria for Adverse Events Version 5
Time Frame
3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ghada Abdallah
Phone
+201008138002
Email
ghadaelsayed2008@yahoo.com
Facility Information:
Facility Name
Assiut university hospital
City
Assiut,
State/Province
Assiut
ZIP/Postal Code
17111
Country
Egypt
Individual Site Status
Active, not recruiting
Facility Name
Assiut university hospital
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Kamal, MD
Phone
+201223971678
Email
mai_heamatology@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Second-line Treatment of Primary Autoimmune Hemolytic Anemia
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