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

Sponsor
Anhui Provincial Hospital
Study ID
NCT06362967
Phase
PHASE2
Status
Recruiting
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Conditions

  • High Titers of Anti-HLA Antibody (MFI ≥5000)

Eligibility Criteria

Sex
ALL
Age
14 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
May 1, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: antibody desensitisation group
    Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG

Primary Outcome Measure

Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment [ Time Frame: at the end of desensitation treatment ]

Central Contacts