Меню
Идёт набор NCT04935684

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Фаза II С лечением Acute Leukemia in Remission Myelodysplastic Syndromes Myeloproliferative Syndrome Hodgkin Lymphoma

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: Fecal Microbiota Transplantation.
Кому может быть актуально
Состояния в реестре: Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome, Hodgkin Lymphoma. Базовые параметры: от 18 лет · 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
Франция
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 →

Официальное название

Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies

Обзор

The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD). The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.

Подробное описание

The TMF-Allo study is a prospective, open-label, multi-center, parallel, randomized phase II clinical trial comparing a group patients with FMT and a control group of patients without FMT.

The main objective of this study is to assess the effect of allogeneic FMT versus no treatment on Graft-versus-host disease and Relapse-Free Survival (GRFS) at one year in adult patients treating with myelo-ablative allo-HSCT for haematologic malignancy.

The secondary objectives are to evaluate :

* Overall survival, progression-free survival at 1 and 2 years, * The haematological evolution, * The evolution of infections, * The tolerance and safety of the TMF carried out in post-transplant, * The evolution of the composition and diversity of the microbiota in allograft patients receiving TMF or not.

Вмешательства

  • Препарат Fecal Microbiota Transplantation
    Patients randomized in the "FMT group" will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT

Первичные конечные точки

  • Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation [Срок оценки: at Day 360 after allogeneic hematopoietic stem cell transplantation]
Вторичные конечные точки (12)
  • Overall survival [Срок оценки: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]
  • Progression-free survival [Срок оценки: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]
  • Haematopoietic reconstitution [Срок оценки: At the time of haematopoietic reconstitution]
  • Engraftment rates [Срок оценки: At Day 30, Day 60, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantationday]
  • Cumulative incidence of acute GvHD [Срок оценки: At Day 360 after allogeneic hematopoietic stem cell transplantation]
  • Cumulative incidence of chronic GvHD [Срок оценки: At Day 720 after allogeneic hematopoietic stem cell transplantation]
  • Transplant-Related Mortality [Срок оценки: At Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]
  • Cumulative incidence of infections [Срок оценки: At Day 360 after allogeneic hematopoietic stem cell transplantation]
  • Severe infections description [Срок оценки: From the day of inclusion to Day 360 after allogeneic hematopoietic stem cell transplantation]
  • Impact of Fecal Microbiota Transplantation (FMT) on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection [Срок оценки: At Day 360 after allogeneic hematopoietic stem cell transplantation]
  • Unexpected event description that could be in relation with FMT of Fecal Microbiota Transplantation (FMT) [Срок оценки: From the day of FMT to Day 360 after allogeneic hematopoietic stem cell transplantation]
  • Quality of life assessment [Срок оценки: at Day -7, Day 30, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]

Критерии участия

Критерии включения

  • Patient aged 18 or over
  • Men and women
  • Patients affiliated with a social-security organization
  • Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood)
  • Signed and dated informed consent

Критерии исключения

  • Status of tumor progression at the time of allo-HSCT
  • Inability to understand the protocol (linguistic barrier, cognitive difficulties)
  • Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)
  • Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)
  • Fecal incontinence
  • Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication.
  • Pregnant women
  • Patient under guardianship, curatorship or protection of justice

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 20 центров
  • Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud — Amiens
  • Service Maladies du sang CHU Angers — Angers
  • Hématologie clinique CHU Besançon — Besançon
  • Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU G — Clermont-Ferrand
  • Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Fer — Clermont-Ferrand
  • Service hématologie CHU Grenoble — Grenoble
  • Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille — Lille
  • Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges — Limoges
  • … и ещё 12 центров

Публикации

  • Douge A, Ravinet A, Corriger A, Cabrespine A, Wasiak M, Pereira B, Sokol H, Nguyen S, Bay JO. Faecal microbiota transplantation to prevent complications after allogeneic stem cell transplantation for haematological malignancies: a study protocol for a randomised controlled phase-II trial (the FMT-allo study). BMJ Open. 2023 May 2;13(5):e068480. doi: 10.1136/bmjopen-2022-068480. PMID 37130682

Идентификаторы

NCT: NCT04935684 · PHRC N 2018 BAY · 2020-000673-24

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗