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Clinical Trials/NCT06395220
NCT06395220CompletedNot Applicable

Kinectics of Donor-specific Anti-HLA Antibody After HLA-incompatible Allogeneic Haematopoietic Stem Cell Transplantation

Peking University People's Hospital1 site in 1 country314 target enrollmentStarted: January 1, 2024Last updated:

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chang Yingjun

Professor and Chief Physician

Peking University

Study Sites (1)

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