Overview
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.
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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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