Clinical trial NCT06395220: Kinectics of Donor-specific Anti-HLA Antibody After HLA-incompatible Allogeneic Haematopoietic Stem Cell Transplantation
Official title: Kinectics of Donor-specific Anti-HLA Antibody After HLA-incompatible Allogeneic Haematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Haematological Malignancy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Peking University First Hospital
name: The First Hospital of Jilin University
name: First Affiliated Hospital of Harbin Medical University
First posted: 2024-05-02
Enrollment: 800
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The basis of sample selection of 800 cases, according to the data of our centre, pre-transplant DSA-positive patients accounted for 11.3% of all transplanted patients, DSA-positive patients given desensitisation treatment before transplantation had a DSA-positive rate of 7% after transplantation, and 710 pre-transplant DSA-negative patients had a post-transplant DSA-positive rate of 7%, so it was 50 cases, and the total number of DSA-positive cases was 56 cases; The above calculations were made without desensitisation of pre-transplant DSA-positive patients and the post-transplant DSA-positive rate of pre-transplant DSA-negative patients was calculated according to pre-transplant DSA-positive patients.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive rates of post-transplantation donor-specific anti-HLA antibody (DSA).
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Acute graft-versus-host disease (aGVHD)
timeFrame: 2 years
measure: Chronic graft-versus-host disease (cGVHD)
timeFrame: 2 years
measure: Neutrophil engraftment
timeFrame: 2 years
measure: Platelet engraftment
timeFrame: 2 years
measure: Primary graft failure
timeFrame: 2 years
measure: Secondary graft-failurefunction
timeFrame: 2 years
measure: Cumulative incidence of relapse
timeFrame: 2 years
measure: Non-relaspe mortality (NRM)
timeFrame: 2 years
measure: Disease-free survival (LFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital of Peking University
Study officials:
References: