Trial | NCT03359980  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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.
Study Started
Aug 13
2018
Primary Completion
Feb 25
2020
Study Completion
Nov 26
2020
Last Update
Feb 23
2021

Drug fecal microbiota transfer

transfer of fecal microbiota from healthy donors to the patients

  • Other names: MaaT013

treated patients Experimental

Treated with Fecal Microbiota Transfer (FMT)

Criteria 

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.
No Results Posted