Spots Global Cancer Trial Database for Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
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Trial Identification
Brief Title: Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
Official Title: Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
Study ID: NCT04935684
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud, Amiens, , France
Service Maladies du sang CHU Angers, Angers, , France
Hématologie clinique CHU Besançon, Besançon, , France
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand, Clermont-Ferrand, , France
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand, Clermont-Ferrand, , France
Service hématologie CHU Grenoble, Grenoble, , France
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille, Lille, , France
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges, Limoges, , France
Service d'Hématologie Centre Hospitalier Lyon Sud, Lyon, , France
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy, Nancy, , France
Service d'Hématologie Clinique CHU Nantes, Nantes, , France
Service d'hématologie clinique, département de greffe de moelle CHU Nice, Nice, , France
Service d'Hématologie Adultes Hôpital Necker, Paris, , France
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière, Paris, , France
Service d'hématologie greffe Hôpital St Louis, Paris, , France
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque, Pessac, , France
Service d'hématologie greffe Hôpital St Louis, Poitiers, , France
Département d'hématologie CAC Rouen, Rouen, , France
Hématologie clinique Institut de Cancérologie de la Loire, Saint-Étienne, , France
IUC T - Oncopôle, Toulouse, , France
Contact Details
Name: Jacques-Olivier BAY, MD, PhD
Affiliation: University Hospital, Clermont-Ferrand
Role: PRINCIPAL_INVESTIGATOR
Name: Stéphanie NGUYEN, MD, PhD
Affiliation: Groupe hospitalier Pitié-Salpêtrière, Paris
Role: PRINCIPAL_INVESTIGATOR
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