Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroids.
- Conditions
- Steroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantationTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-002697-39-FR
- Lead Sponsor
- MaaT Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
-Patients who develop a first episode of Stage 3 or 4 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
-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 (for patient who received antibiotics MaaT Pharma advises against the use of antibiotics (commonly used) with significant digestive excretion (for example but not limited to: metronidazol, ceftriaxone, levofloxacin))
-Signature of informed and written consent by the subject or by the subject’s legally acceptable representative
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
-Grade IV hyper-acute GVHD as defined by the MD Anderson’s criteria (Saliba RM, 2007)
-Late onset aGVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
-Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
-Acute GVHD after donor lymphocytes infusion (DLI)
-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 109 /L
-Absolute platelet count < 10 000
-Patient EBV negative
-Evidence of toxic megacolon or gastrointestinal perforation on abdominal X-ray
-Known allergy or intolerance to trehalose or maltodextrin or latex
-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method