Treatment to reduce anti-HLA antibodies before stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of a desensitization regimen that includes immunoadsorption 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 (allo-HSCT). It aims to lower the antibody levels in patients with mean fluorescence intensity (MFI) ≥ 5000, which is associated with higher risks of transplant complications. The study will be conducted as a single-arm prospective cohort study to assess the impact of this treatment on reducing transplant-related complications and improving patient outcomes.

Why it matters

Who can join: the full rules

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)

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Xiaoyu Zhu, ph.D. — The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
• Study coordinator: Xiaoyu Zhu, ph.D.
• Email: xiaoyuz@ustc.edu.cn
• Phone: 15255456091

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.