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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

• Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment [Срок оценки: at the end of desensitation treatment]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Хэфэй

Идентификаторы

NCT: NCT06362967 · Anti-HLA antibody

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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