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

NCT06395220 | Completed

• 1 other identifier: PekingUPH Chang Yingjun
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Haematological Malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Acute graft-versus-host disease (aGVHD)

  2 years

• Chronic graft-versus-host disease (cGVHD)

  2 years

• Neutrophil engraftment

  2 years

• Platelet engraftment

  2 years

• Primary graft failure

  2 years

Interventions

Detection of donor-specific anti-HLA antibody (DSA) OTHER

Detection methods 1. . Morphology: using microscope to observe the morphology of bone marrow. 2. . Immunophenotyping: using multi-color flow cytometry (MFC) to detect immunophenotype of leukemia cells and leukemia-associated immunophenotype of bone marrow samples. 3. . Cytogenetics analysis: G-band and/or fluorescence in situ hybridization (FISH) analysis are used in this study 4. . Molecular detection: Real-time quantitative RT-PCR (RQ-PCR) and/or next generation sequencing techniques are used to detect the molecular marker, such as: PML/RARA, AML-ETO, BCR/ABL, and WT1. 5. . HLA-Typing: HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 alleles were determined according to the literatures published by our group \[Huo MR, et al. Bone Marrow Transplant. 2018;53(5):600-608\].. 6. . Other analyses: Detection of minimal residual diseases were performed using MFC and RQ-PCR according to the methods reported by our group \[Li SQ, et al. Blood,2022;140(5):516-520\].

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Clinical diagnosis haematological disorders undergoing HLA-incompatible allogeneic haematopoietic stem cell transplantation Between 15 and 60 years-old Must sign the informed consent

You may not qualify if:

• Withdraw of the signed informed consent for any reason Lack of ability to provide consent due to psychiatric or physical illness

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: collaborator
• Peking University First Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Peking University People's Hospital: lead

Study Sites (1)

People's Hospital of Peking University

Beijing, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)