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Haematological MalignancyNCT06395220

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

An observational study of Haematological Malignancy, run by Peking University People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 60 years
Conditions the study is for
Haematological Malignancy
What is being tested?
Detection of donor-specific anti-HLA antibody (DSA)
How many people
314 participants
Where
1 siteChina
Study dates
1 Jan 2024to 1 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 60 years
  • All sexes
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • People's Hospital of Peking University

    Beijing

Other trials in China

About this study

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.

Being tested
Detection of donor-specific anti-HLA antibody (DSA)
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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].

What is being measured

The primary outcome is the main question the study is designed to answer.

  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].

    Measured: through study completion, an average of 2 years

Secondary outcomes (10)

  1. 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.].

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 2 years

  5. 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).

    Measured: 2 years

  6. Secondary graft-failurefunction

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

    Measured: 2 years

  7. 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.

    Measured: 2 years

  8. 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.

    Measured: 2 years

  9. Disease-free survival (LFS)

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

    Measured: 2 years

  10. Overall survival (OS)

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2024
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395220
Sponsor's protocol ID
PekingUPH Chang Yingjun
Status last verified
Dec 2025
First submitted
24 Apr 2024
Last updated
2 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Haematological Malignancy, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive rates of post-transplantation donor-specific anti-HLA antibody (DSA). (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06395220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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