Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG
Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG: For allogeneic haematopoietic stem cell transplantation patients with high titers of anti-HLA antibodies present in the body, a desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG is used prior to transplantation.
Study 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
Sex
ALL
Min age
14 Years
Max age
60 Years
Healthy volunteers
No
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 disorders and persons with cognitive dysfunction
6. Participants in other clinical studies within 3 months
7. Those whom the investigator considers unsuitable for enrolment (e.g., subjects will not be able to adhere to examinations and treatments due to financial or other issues)
Primary outcome measure(s)
Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment — at the end of desensitation treatment Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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