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

NCT ID: NCT03359980

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2020-11-26

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.

Conditions

Fecal Microbiota Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treated patients

Treated with Fecal Microbiota Transfer (FMT)

Group Type: EXPERIMENTAL

fecal microbiota transfer

Intervention Type: DRUG

transfer of fecal microbiota from healthy donors to the patients

Interventions

fecal microbiota transfer

transfer of fecal microbiota from healthy donors to the patients

Intervention Type: DRUG

Other Intervention Names

MaaT013

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MaaT Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florent Malard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Antoine - PARIS

Locations

CHU Amiens

Amiens, , France

CHU Angers

Angers, , France

CHRU Besançon

Besançon, , France

Hôpital Henri Mondor

Créteil, , France

CHRU Lille

Lille, , France

CHU Limoges

Limoges, , France

CHU Nantes

Nantes, , France

Hôpital Saint Antoine

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

CHU Strasbourg

Strasbourg, , France

IUCT Oncopole

Toulouse, , France

Gemelli Hospital

Roma, , Italy

Klinika Hematologii i Transplantologii

Gdansk, , Poland

Public Clinic Hospital

Katowice, , Poland

University Clinical hospital

Wroclaw, , Poland

Countries

France; Italy; Poland

References

Malard F, Loschi M, Huynh A, Cluzeau T, Guenounou S, Legrand F, Magro L, Orvain C, Charbonnier A, Panz-Klapuch M, Desmier D, Mear JB, Cornillon J, Robin C, Daguindau E, Bilger K, Vehreschild MJGT, Chevallier P, Labussiere-Wallet H, Mediavilla C, Couturier MA, Bulabois CE, Camus V, Chantepie S, Ceballos P, Gaugler B, Holler E, Dore J, Prestat E, Gasc C, Plantamura E, Mohty M. Pooled allogeneic faecal microbiota MaaT013 for steroid-resistant gastrointestinal acute graft-versus-host disease: a single-arm, multicentre phase 2 trial. EClinicalMedicine. 2023 Jul 26;62:102111. doi: 10.1016/j.eclinm.2023.102111. eCollection 2023 Aug.

Reference Type: DERIVED

PMID: 37654670 (View on PubMed)

Other Identifiers

MPOH03

Identifier Type: -

Identifier Source: org_study_id