Second-line Treatment of Primary Autoimmune Hemolytic Anemia

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Autoimmune Hemolytic Anemia
• Intervention / Treatment: Drug: Cyclosporine; Drug: Rituximab

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ghada Abdallah; Phone Number: +201008138002; Email: ghadaelsayed2008@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University Hospital
    • Contact: Mai Kamal, MD; Phone Number: +201223971678; Email: mai_heamatology@aun.edu.eg
  • Assiut
    • Assiut,, Assiut, Egypt, 17111
      • Active, not recruiting
      • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of adverse events	according to Common Terminology Criteria for Adverse Events Version 5	3months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2021
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 30, 2022

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (ACTUAL): September 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Anemia; Hemolysis; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Rituximab; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 17300534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No