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

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 Overview

• Status: Completed
• Conditions: Haematological Malignancy
• Intervention / Treatment: Other: Detection of donor-specific anti-HLA antibody (DSA)

• Study Type: Observational
• Enrollment (Actual): 314

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • People's Hospital of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rates of post-transplantation donor-specific anti-HLA antibody (DSA).	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].	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute graft-versus-host disease (aGVHD)	Acute GVHD was defined and graded from I to IV based on the pattern and severity of organ involvement [Sullivan KM. Graft-versus-host-disease. In: Thomas ED, Blume KG, Forman SJ (eds). Hematopoietic Cell Transplantation. 5nd edn. Blackwell Science: Boston, MA, USA, 2020, pp 515-536.].	2 years
Chronic graft-versus-host disease (cGVHD)	Chronic GVHD was defined and graded according to the National Institute of Health criteria:[Biol Blood Marrow Transplant,2005,11: 945] that is, mild cGVHD reflects the involvement of no more than 1 or 2 organs/sites (except for lung) with a maximum score of 1; moderate cGVHD involves at least 1 organ/site with a score of 2 or ≥3 organs/sites with a score of 1 (or lung score 1); and severe cGVHD is diagnosed when a score of 3 is given to any organ (or lung score 2). The diagnosis is mainly based on clinical manifestations.	2 years
Neutrophil engraftment	Neutrophil engraftment was defined as the first day of an absolute neutrophil count above 0.5×109/L for three consecutive days after the neutrophil nadir.	2 years
Platelet engraftment	Platelet engraftment was defined as the first of 7 consecutive days during which the platelet count was at least 20×109/L without needing transfusion.	2 years
Primary graft failure	Primary graft failure was defined as never achieved an ANC >0.5×109/L for thress consecutive days or an ANC >0.5×109/L without donor engraftment (autologous recovery).	2 years
Secondary graft-failurefunction	Secondary graft-failure was defined as decline or loss of donor engraftment.	2 years
Cumulative incidence of relapse	Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of transplantation to the date of disease recurrence. Patients exhibiting minimal residual disease (for example, the presence of BCR/ABL RNA transcripts by PCR) were not classified as having morphological relapse.	2 years
Non-relaspe mortality (NRM)	Non-relapse mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation.	2 years
Disease-free survival (LFS)	Disease-free survival was defined as days from transplantation to disease progression after transplantation.	2 years
Overall survival (OS)	Overall survival referred to patients who survived until the final follow-up time point.	2 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University First Hospital; The First Affiliated Hospital of Zhengzhou University; The First Hospital of Jilin University; First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: PekingUPH Chang Yingjun

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No