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RecruitingPhase 2NCT06362967

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

The Efficacy and Safety of Immunosorbent or Plasma Exchange Combined With Rituximab and High-dose IVIG for Patients With High Titers of Anti-HLA Antibodies Prior to Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Centre, Single-Arm, Phase II Clinical Study

Sponsor

Anhui Provincial Hospital

Enrollment

30 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 14 YearsMax Age: 60 Years

Inclusion Criteria6

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

Exclusion Criteria7

  • Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas
  • Pregnancy
  • Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment
  • 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
  • Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction
  • Participants in other clinical studies within 3 months
  • 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)

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Interventions

COMBINATION_PRODUCTImmunoadsorption or plasma exchange combined with rituximab, high-dose IVIG

For allogeneic haematopoietic stem cell transplantation patients with high titers of anti-HLA antibodies present in the body, a desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG is used prior to transplantation.

Locations(1)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

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NCT06362967