Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies (TMF-Allo)

NCT04935684 Phase 2 RECRUITING

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.

Details

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	Phase 2
Status	RECRUITING
Enrolment	150
Start date	2022-12-20
Completion	2027-12

Conditions

• Acute Leukemia in Remission
• Myelodysplastic Syndromes
• Myeloproliferative Syndrome
• Hodgkin Lymphoma
• Lymphoma, Non-Hodgkin
• Myeloma
• Chronic Lymphocytic Leukemia

Interventions

• Fecal Microbiota Transplantation

Primary outcomes

• Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation — at Day 360 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.

Countries

France