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Clinical Trials in China / NCT06362967
Recruiting Phase 2

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

NCT06362967 · tracked via the Priya Life Science China tracker
Sponsor
Anhui Provincial Hospital
Phase
Phase 2
Started
2024-05-01
Last updated
2024-12-18

Condition(s) studied

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

Investigational drug(s) / intervention(s)

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

Immunoadsorption 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.

Study 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

Sex
ALL
Min age
14 Years
Max age
60 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

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

More Anhui Provincial Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06362967 on ClinicalTrials.gov ↗ ← All trials in China