Status:
COMPLETED
Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
Lead Sponsor:
MaaT Pharma
Conditions:
Fecal Microbiota Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03359980
Start Date
August 13 2018
End Date
November 26 2020
Last Update
February 23 2021
Active Locations (16)
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1
CHU Amiens
Amiens, France, 80054
2
CHU Angers
Angers, France, 49933
3
CHRU Besançon
Besançon, France, 25030
4
Hôpital Henri Mondor
Créteil, France, 94000