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Recruiting Phase 2 NCT06362967

The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT

Trial Parameters

Condition High Titers of Anti-HLA Antibody (MFI ≥5000)
Sponsor Anhui Provincial Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 14 Years
Max Age 60 Years
Start Date 2024-05-01
Completion 2026-12-31
Interventions
Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG

Brief Summary

Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation

Eligibility Criteria

Inclusion Criteria: 1. Subjects to undergo allo-HSCT 2. Age 14-60, No gender, No ethnicity 3. ECOG score ≤ 2 4. Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000 5. No severe organ failure and no active infections 6. Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form Exclusion Criteria: 1. Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas 2. Pregnancy 3. Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment 4. Persons with any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject and place the results of the study at unnecessary risk 5. Persons with drug dependence,uncontrolled psychiatric disorder

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