Меню
Идёт набор NCT05700565

Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype

— Наблюдательное Immune-related Adverse Event

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Extracorporeal photopheresis, Other immunosuppressive or immunomodulatory drugs.
Кому может быть актуально
Состояния в реестре: Immune-related Adverse Event. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study is an open, monocentric study. It includes patients with irAE refractory to standard therapy or patients where corticosteroids cannot be tapered. Patients will either be treated with ECP or second line immunosuppressive therapy according to investigator's choice. Patients will be followed for 24 weeks after first treatment.

Подробное описание

At inclusion patient history including type of tumor and immunotherapy will be obtained.

At all visits symptoms, changes in concomitant medication, a medical assessment and laboratory investigations will be performed. Blood sampling for safety analysis and for investigating the immunophenotype will be performed at baseline, week 1, 4, 8 and 12.

Laboratory values assessed include:

* Complete blood count * Chemistry including liver enzymes (AST, ALT) and total bilirubin in the case of immune-related hepatitis, CK in case of myositis, creatinine in case of nephritis * Inflammatory markers: CRP, IL-6, Procalcitonin Peripheral blood mononuclear cells (PBMC) will be used to determine immunophenotype, including the amount of NK-cells, regulatory T- cells and myeloid-derived suppressor cells (MDSC) as well as the expression of inflammatory markers. Biological samples will be frozen for later analysis.

Additionally, patients will assess their symptoms and their quality of life by a self-administered questionnaire at baseline and week 4, 8 and 12. Quality of life will be assessed by EORTC QLQ-C30. All irAE will be graded according to CTCAE.

Вмешательства

  • Другое Extracorporeal photopheresis
    ECP consists of the three steps of leukapheresis, photoactivation and reinfusion and has immunomodulatory effects (modulation of dendritic cells, change in cytokine profile, induction of T cell subpopulations). Indications are currently the treatment of Sézary syndrome, Graft-versus-host disease (GvHD), organ transplant rejection and systemic scleroderma.
  • Другое Other immunosuppressive or immunomodulatory drugs
    Other immunosuppressive or immunomodulatory drugs

Первичные конечные точки

  • Immunophenotype [Срок оценки: 12 weeks]
Вторичные конечные точки (2)
  • Developement of grade of irAE [Срок оценки: 12 weeks]
  • Patient quality of life [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.
  • irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade)
  • irAE refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent <= 5mg. An irAE is defined as refractory if corticosteroids do not improve symptoms within 72 hours. The inability to taper corticosteroids is defined as relapse on standard tapering of 1 mg/kg corticosteroid over 28 days.

Критерии исключения

  • Contraindications for the treatment with ECP including a known sensitivity to psoralen compounds such as 8-MOP, comorbidities that may result in photosensitivity, aphakia, history of heparin-induced thrombocytopenia, unsatisfactory cardio-circulatory function, low hematocrit values
  • Pregnancy
  • Body weight less than 40 kg.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • LMU Klinikum Hauttumorzentrum — Munich

Публикации

  • Wein L, Ertl C, Ruf T, Morak M, Wang Y, Schmitt C, Garza Vazquez X, Glatzel V, David-Rus R, Mitwalli M, Srour J, Schopf P, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis versus systemic immunosuppression for treatment of immune-related adverse events: clinical outcomes from the prospective two-arm PRIA study. J Immunother Cancer. 2026 Jun 12;14(6):e015185. doi: 10.1136/jitc-2026 PMID 42285609
  • Ertl C, Ruf T, Hammann L, Piseddu I, Wang Y, Schmitt C, Garza Vazquez X, Kabakci C, Bonczkowitz P, de Toni EN, David-Rus R, Srour J, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis vs. systemic immunosuppression for immune-related adverse events: Interim analysis of a prospective two-arm study. Eur J Cancer. 2024 Nov;212:115049. doi: 10.1016/j.ejca.2024.115049. Epub 2024 Sep 27. PMID 39383612

Идентификаторы

NCT: NCT05700565 · LMUKlinikum

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗