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Completed

NCT Number: NCT06395220

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.

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Key information

Conditions

Haematological Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

People's Hospital of Peking University

Beijing, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Detection methods

  • . Morphology: using microscope to observe the morphology of bone marrow.
  • . Immunophenotyping: using multi-color flow cytometry (MFC) to detect immunophenotype of leukemia cells and leukemia-associated immunophenotype of bone marrow samples.
  • . Cytogenetics analysis: G-band and/or fluorescence in situ hybridization (FISH) analysis are used in this study
  • . 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.
  • . 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]..
  • . 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].

Primary outcomes

  1. 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

  1. Acute graft-versus-host disease (aGVHD)

    Time frame: 2 years

    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. Chronic graft-versus-host disease (cGVHD)

    Time frame: 2 years

    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.

  3. Neutrophil engraftment

    Time frame: 2 years

    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.

  4. Platelet engraftment

    Time frame: 2 years

    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.

  5. Primary graft failure

    Time frame: 2 years

    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).

  6. Secondary graft-failurefunction

    Time frame: 2 years

    Secondary graft-failure was defined as decline or loss of donor engraftment.

  7. Cumulative incidence of relapse

    Time frame: 2 years

    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.

  8. Non-relaspe mortality (NRM)

    Time frame: 2 years

    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.

  9. Disease-free survival (LFS)

    Time frame: 2 years

    Disease-free survival was defined as days from transplantation to disease progression after transplantation.

  10. Overall survival (OS)

    Time frame: 2 years

    Overall survival referred to patients who survived until the final follow-up time point.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • First Affiliated Hospital of Harbin Medical University
  • Peking University First Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The First Hospital of Jilin University

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 2, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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