Combined high titre anti-HLA antibodies prior to allogeneic haematopoietic stem cell transplantation
Conditions
Interventions
antibody desensitisation group:Immunoadsorption combined with rituximab, high-dose IVIG
Sponsors
the frist affiliated hospital of USTC(Anhui provincial hospital)
Eligibility
Sex/Gender
All
Age
14 Years to 60 Years
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of reduction of anti-HLA antibody MFI values to within 5000 in subjects at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of primary graft failure;100 day Transplant-related mortality (TRM) after allo-HSCT;Incidence of ineffective platelet transfusion after allo-HSCT;Cumulative incidence of neutrophil engraftment after allo-HSCT;Cumulative incidence of II-IV° acute GVHD;Cumulative incidence of relapse at 1 year post-transplant;1 year overall survival post transplantation; | — |
Countries
China
Contacts
Public ContactXiaoyu Zhu
the frist affiliated hospital of USTC(Anhui provincial hospital)
Outcome results
None listed