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

Phase 2RecruitingNCT06362967

Anhui Provincial Hospital30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIGCOMBINATION_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.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

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

Hefei, Anhui, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment

Time frame: at the end of desensitation treatment

Secondary Outcomes

Incidence of primary graft failure

Time frame: 42 days

Incidence of TRM after allo-HSCT

Time frame: 100 days

Incidence of ineffective platelet transfusion after allo-HSCT

Time frame: 100 days

Cumulative incidence of neutrophil engraftment after allo-HSCT

Cumulative incidence of neutrophil engraftment after allo-HSCT cumulative incidence of neutrophil engraftment after allo-HSCT

Time frame: 42 dyas

Cumulative incidence of II-IV° acute GVHD

Time frame: 100 days

Cumulative incidence of relapse at 1 year post-transplant

Time frame: 360 days

Probability of overall survival post transplantation

Central Contacts

Xiaoyu Zhu, ph.D.

CONTACT

15255456091 xiaoyuz@ustc.edu.cn

Yue Wu, M.D.

CONTACT

13805601119 287109658@qq.com

Data from ClinicalTrials.gov

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