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

Phase 2

Recruiting

• Conditions: High Titers of Anti-HLA Antibody (MFI ≥5000)
• Interventions: Combination Product: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG

• Registration Number: NCT06362967
• Lead Sponsor: Anhui Provincial Hospital

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.

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Start: 2024-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
antibody desensitisation group	Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG	Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of II-IV° acute GVHD	100 days	Cumulative incidence of II-IV° acute GVHD
Cumulative incidence of relapse at 1 year post-transplant	360 days	Cumulative incidence of relapse at 1 year post-transplant
Probability of overall survival post transplantation	360 days	Probability of overall survival post transplantation
Incidence of primary graft failure	42 days	Incidence of primary graft failure
Incidence of TRM after allo-HSCT	100 days	Incidence of TRM after allo-HSCT
Incidence of ineffective platelet transfusion after allo-HSCT	100 days	Incidence of ineffective platelet transfusion after allo-HSCT
Cumulative incidence of neutrophil engraftment after allo-HSCT	42 dyas	Cumulative incidence of neutrophil engraftment after allo-HSCT cumulative incidence of neutrophil engraftment after allo-HSCT
Incidence of allergies and allergic reactions	at the end of desensitation treatment	Incidence of allergies and allergic reactions
Incidence of viral, bacterial and fungal infections	at the end of desensitation treatment	Incidence of viral, bacterial and fungal infections
Incidence of haemorrhagic events	at the end of desensitation treatment	Incidence of haemorrhagic events
Incidence of hypocalcaemia	at the end of desensitation treatment	Incidence of hypocalcaemia

Trial Locations

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital); 🇨🇳 Hefei, Anhui, China