Treatment to reduce anti-HLA antibodies before stem cell transplantation

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

This study is testing a new treatment to lower harmful antibodies in patients with high levels before they receive a stem cell transplant, to see if it helps them have fewer complications and better outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 14 Years to 60 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Drugs / interventions: rituximab
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06362967 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a desensitization regimen that includes immunoadsorption 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 (allo-HSCT). It aims to lower the antibody levels in patients with mean fluorescence intensity (MFI) ≥ 5000, which is associated with higher risks of transplant complications. The study will be conducted as a single-arm prospective cohort study to assess the impact of this treatment on reducing transplant-related complications and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14-60 undergoing allo-HSCT with high titers of anti-HLA antibodies (MFI ≥ 5000).

Not a fit: Patients with severe organ dysfunction, active infections, or those who refuse the desensitization treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve transplant success rates and reduce complications for patients with high anti-HLA antibody levels.

How similar studies have performed: Other studies have shown promise in using similar desensitization approaches, but this specific regimen is being evaluated for the first time in this context.

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)

Where this trial is running

Hefei, Anhui

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

Study contacts

• Principal investigator: Xiaoyu Zhu, ph.D. — The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
• Study coordinator: Xiaoyu Zhu, ph.D.

Conditions High Titers of Anti-HLA Antibody; immunoadsorption or plasma exchange；rituximab；high-dose IVIG