Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer (HERACLES)

MaaT Pharma

Status and phase

Completed

Phase 2

Conditions

Fecal Microbiota Transplantation

Treatments

Drug: fecal microbiota transfer

Study type

Interventional

Funder types

Industry

Identifiers

NCT03359980

MPOH03

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.