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

NCT ID: NCT06362967

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-06-30

Brief 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

Detailed 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.

Conditions

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

Keywords

immunoadsorption or plasma exchange；rituximab；high-dose IVIG

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

antibody desensitisation group

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

Group Type: EXPERIMENTAL

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

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Intravenous Immunoglobin

Eligibility Criteria

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyu Zhu, ph.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

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

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyu Zhu, ph.D.

Role: CONTACT

Phone: 15255456091

Email: xiaoyuz@ustc.edu.cn

Yue Wu, M.D.

Role: CONTACT

Phone: 13805601119

Email: 287109658@qq.com

Facility Contacts

Xiaoyu Zhu, ph.D

Role: primary

Yue Wu, M.D

Role: backup

Other Identifiers

Anti-HLA antibody

Identifier Type: -

Identifier Source: org_study_id