Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer
Lead SponsorMaaT Pharma
StatusCompleted No Results Posted
Indication/ConditionFecal Microbiota Transplantation
Intervention/Treatmentfecal microbiota transfer
Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.
transfer of fecal microbiota from healthy donors to the patients
Treated with Fecal Microbiota Transfer (FMT)
Inclusion Criteria: Patients who develop a first episode of Stage 2 to 4 Gastro-intestinal Acute Graft-versus-Host (GI-aGVHD) with gut predominance (Przepiorka D, 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose) (SR GI-aGVHD) Age ≥ 18 years old Allogeneic Hematopoietic stem cell transplantation (Allo-HSCT) with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT Signature of informed and written consent by the subject or by the subject's legally acceptable representative Exclusion Criteria: Grade IV hyper-acute GVHD Overlap chronic GVHD Acute GVHD after donor lymphocytes infusion Relapsed/persistent malignancy requiring rapid immune suppression withdrawal Active uncontrolled infection according to the attending physician Other systemic drugs than corticosteroids for GVHD treatment (including extra-corporeal photopheresis). Drugs already being used for GVHD prevention (eg. calcineurin inhibitors) are allowed. Absolute neutrophil count < 0.5 x 10^9 /L Absolute platelet count < 10 000 Patient Epstein-Barr Virus (EBV) negative Evidence of toxic megacolon or gastrointestinal perforation on abdominal X-ray Known allergy or intolerance to trehalose or maltodextrin Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female of childbearing potential Other ongoing interventional protocol that might interfere with the current study primary endpoint.