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.
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)
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)
Parallel
Fecal Microbiota Transplantation
DrugPatients 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. The enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes.
Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation
GRFS is a composite endpoint of GvHD-free/relapse-free survival in which events include grade II-IV acute GvHD, moderate and severe chronic GvHD, relapse, or death in the first year post-HSCT. GRFS will be measured at one year after allo-HSCT and compared between both groups of patients.
Overall survival
Overall survival is defined as the time period between the date of randomization and the date of death, regardless of its cause.
Progression-free survival
Progression-free survival is defined as the time period between the date of randomization and the date of disease relapse or progression or death, regardless of its cause.
Haematopoietic reconstitution
Haematopoietic reconstitution is assessed by: 1/ turnaround time of polynuclear neutrophils \>0.5.10\^9/L (first day within a period of three consecutive days); 2/ spontaneous platelet turnaround time \>20.10\^9/L (two days with no platelet transfusion within the previous three days); 3/ spontaneous platelet turnaround time \>50.10\^9/L (two days with no platelet transfusion within the previous three days); 4/ the number of transfusions of red blood cells and platelets between D0 and D100
Engraftment rates
Engraftment rates are evaluated by a chimerism measure (by molecular biology)
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University Hospital, Clermont-Ferrand
Lead sponsor
Ministry of Health, France
Collaborator
French Society of Hematology
Collaborator
