The Efficacy and Safety of Immunosorbent or Plasma Exchange Combined With Rituximab and High-dose IVIG for Patients With High Titers of Anti-HLA Antibodies Prior to Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Centre, Single-Arm, Phase II Clinical Study
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 60
Healthy Volunteers: f
View:
• Subjects to undergo allo-HSCT
• Age 14-60, No gender, No ethnicity
• ECOG score ≤ 2
• Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000
• No severe organ failure and no active infections
• Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form
Locations
Other Locations
China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
RECRUITING
Hefei
Contact Information
Primary
Xiaoyu Zhu, ph.D.
xiaoyuz@ustc.edu.cn
15255456091
Backup
Yue Wu, M.D.
287109658@qq.com
13805601119
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 30
Treatments
Experimental: antibody desensitisation group
Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital