Actively Recruiting

Phase 2
Age: 14Years - 60Years
All Genders
NCT06362967

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

Led by Anhui Provincial Hospital · Updated on 2024-12-18

30

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT)
  • Age between 14 and 60 years, any gender or ethnicity
  • ECOG performance status score of 2 or less
  • Presence of HLA-class I or class II antibodies with MFI 5000 or higher within 1 month before transplantation
  • No severe organ failure and no active infections
  • Willingness of patients and their families to undergo anti-HLA antibody testing and desensitisation treatment and to provide informed consent
Not Eligible

You will not qualify if you...

  • Severe disease or dysfunction of the heart, liver, kidneys, or pancreas
  • Pregnancy
  • Refusal by patient or authorized family members to accept antibody desensitisation treatment
  • Any life-threatening disease or organ dysfunction that may risk patient safety or study results as judged by the investigator
  • Drug dependence, uncontrolled psychiatric disorders, or cognitive dysfunction
  • Participation in another clinical study within the past 3 months
  • Investigator judgment of unsuitability for enrollment due to inability to adhere to examinations or treatments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Hefei, Anhui, China, 230036

Actively Recruiting

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Research Team

X

Xiaoyu Zhu, ph.D.

CONTACT

Y

Yue Wu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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