Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

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.

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