The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG.
- Who it may be relevant to
- Registry conditions: High Titers of Anti-HLA Antibody (MFI ≥5000). Basic parameters: 14 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy and Safety of Immunosorbent 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: A Single-Centre, Single-Arm, Phase II Clinical Study
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
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.
Interventions
- Combination product 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.
Primary outcome measures
- 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 outcome measures (11)
- 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 [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 [Time frame: 360 days]
- Incidence of allergies and allergic reactions [Time frame: at the end of desensitation treatment]
- Incidence of haemorrhagic events [Time frame: at the end of desensitation treatment]
- Incidence of viral, bacterial and fungal infections [Time frame: at the end of desensitation treatment]
- Incidence of hypocalcaemia [Time frame: at the end of desensitation treatment]
Eligibility criteria
Inclusion criteria
- Subjects to undergo allo-HSCT
- Age 14-60, No gender, No ethnicity
- ECOG score ≤ 2
- Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000
- No severe organ failure and no active infections
- Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form
Exclusion criteria
- Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas
- Pregnancy
- Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment
- 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
- Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction
- Participants in other clinical studies within 3 months
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Hefei
Identifiers
NCT: NCT06362967 · Anti-HLA antibody