Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
- Conditions
- Fecal Microbiota Transplantation
- Interventions
- Drug: fecal microbiota transfer
- Registration Number
- NCT03359980
- Lead Sponsor
- MaaT Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treated patients fecal microbiota transfer Treated with Fecal Microbiota Transfer (FMT)
- Primary Outcome Measures
Name Time Method Efficacy of FMT in the treatment of Steroid Refractory -Gastro-intestinal Acute GVHD (SR-GI-aGVHD) at D28 post inclusion up to 4 weeks post inclusion Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR)
- Secondary Outcome Measures
Name Time Method Number of patients with Chronic GVHD through study completion, an average of six months Chronic GVHD expression
Gastrointestinal GVHD overall response rate at D28 post inclusion Day 28 Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR) or Partial Response (PR)
Number of multidrug resistant bacteria in faeces through study completion, an average of six months Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage
Safety of FMT in patients with SR-GI-aGVHD through study completion, an average of six months The overall safety of the study will be evaluated with the incidence of all Adverse Events (AEs) and Serious Adverse Events (SAEs) (frequency, grade, relationship) throughout the study period
Number of patients with infectious disorders through study completion, an average of six months Evaluation of FMT activity on infectious disorders
Trial Locations
- Locations (16)
CHU Amiens
🇫🇷Amiens, France
CHU Limoges
🇫🇷Limoges, France
CHRU Besançon
🇫🇷Besançon, France
Gemelli Hospital
🇮🇹Roma, Italy
Klinika Hematologii i Transplantologii
🇵🇱Gdańsk, Poland
CHU Strasbourg
🇫🇷Strasbourg, France
Hôpital Henri Mondor
🇫🇷Créteil, France
Public Clinic Hospital
🇵🇱Katowice, Poland
Institut de Cancérologie de la Loire
🇫🇷Saint-Priest-en-Jarez, France
IUCT Oncopole
🇫🇷Toulouse, France
CHU Angers
🇫🇷Angers, France
CHRU Lille
🇫🇷Lille, France
CHU Nantes
🇫🇷Nantes, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
Hôpital Saint Antoine
🇫🇷Paris, France
University Clinical hospital
🇵🇱Wroclaw, Poland