Myelodysplastic Syndromes Clinical Trial
Official title:
Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
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.
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. ;
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