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The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT

U

University of Science and Technology of China (USTC)

Status and phase

Not yet enrolling
Phase 2

Conditions

High Titers of Anti-HLA Antibody (MFI ≥5000)

Treatments

Combination Product: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG

Study type

Interventional

Funder types

Other

Identifiers

NCT06362967
Anti-HLA antibody

Details and patient eligibility

About

Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation

Full description

Approximately 10-21% of allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients have non-specific or donor-specific anti-HLA antibodies (DSAs) prior to transplantation. Patients with combined DSAs and mean fluorescence intensity (MFI) ≥ 5000 can lead to a significantly higher incidence of primary graft failure and graft dysfunction after transplantation, and increased transplant-related mortality (TRM). Meanwhile, a retrospective study at our centre found that patients with high titre non-specific antibodies (MFI ≥ 5000) present before cord blood transplantation had significantly higher TRM in the early post-transplantation period. Therefore, our centre intends to conduct a single-arm prospective cohort study to explore whether the desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG before transplantation in allogeneic hematopoietic stem cell transplantation patients with high titres of anti-HLA antibodies can lower the antibody titres in the patient's body, reduce the incidence of transplant-related complications, and improve the prognosis of transplantation.

Enrollment

30 estimated patients

Sex

All

Ages

14 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subjects to undergo allo-HSCT
  2. Age 14-60, No gender, No ethnicity
  3. ECOG score ≤ 2
  4. Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000
  5. No severe organ failure and no active infections
  6. Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form

Exclusion criteria

  1. Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas
  2. Pregnancy
  3. Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment
  4. Persons with any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject and place the results of the study at unnecessary risk
  5. Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction
  6. Participants in other clinical studies within 3 months
  7. Those whom the investigator considers unsuitable for enrolment (e.g., subjects will not be able to adhere to examinations and treatments due to financial or other issues)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

antibody desensitisation group
Experimental group
Description:
Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG
Treatment:
Combination Product: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG

Trial contacts and locations

1

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Central trial contact

Yue Wu, M.D.; Xiaoyu Zhu, ph.D.

Data sourced from clinicaltrials.gov

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