Kinectics of Donor-specific Anti-HLA Antibody After HLA-incompatible Allogeneic Haematopoietic Stem Cell Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 314
- Locations
- 1
- Primary Endpoint
- Positive rates of post-transplantation donor-specific anti-HLA antibody (DSA).
Study Overview
Brief Summary
Donor specific anti-HLA antibody (DSA) is closely related not only to primary graft rejection (GR) after HLA-incompatible transplantation, but also to the occurrence of primary PGF. Desensitisation therapy can reduce the level of DSA in patients and decrease the incidence of PGF after transplantation. However, most studies at home and abroad have focused on DSA levels in recipients before transplantation, risk factors and their effects on prognosis. Very few studies have focused on the rate of DSA positivity and its risk factors after transplantation. Therefore, this project aims to clarify the rate of DSA positivity after HLA-incompatible Allo-HSCT and reveal the influencing factors of post-transplantation DSA positivity with the help of a prospective, registry-based clinical cohort of HLA-incompatible transplant recipients, in order to provide a basis for the prevention and treatment of DSA-induced graft rejection or PGF.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis haematological disorders undergoing HLA-incompatible allogeneic haematopoietic stem cell transplantation Between 15 and 60 years-old Must sign the informed consent
Exclusion Criteria
- •Withdraw of the signed informed consent for any reason Lack of ability to provide consent due to psychiatric or physical illness
Outcomes
Primary Outcomes
Positive rates of post-transplantation donor-specific anti-HLA antibody (DSA).
Time Frame: through study completion, an average of 2 years
HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 alleles were determined according to the literatures published by our group \[Huo MR, et al. Bone Marrow Transplant. 2018;53(5):600-608\].
Secondary Outcomes
- Acute graft-versus-host disease (aGVHD)(2 years)
- Chronic graft-versus-host disease (cGVHD)(2 years)
- Platelet engraftment(2 years)
- Primary graft failure(2 years)
- Non-relaspe mortality (NRM)(2 years)
- Cumulative incidence of relapse(2 years)
- Overall survival (OS)(2 years)
- Neutrophil engraftment(2 years)
- Secondary graft-failurefunction(2 years)
- Disease-free survival (LFS)(2 years)
Investigators
Chang Yingjun
Professor and Chief Physician
Peking University