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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359980
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fecal Microbiota Transplantation Drug: fecal microbiota transfer Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : November 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: treated patients
Treated with Fecal Microbiota Transfer (FMT)
 Drug: fecal microbiota transfer
transfer of fecal microbiota from healthy donors to the patients
Other Name: MaaT013


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of FMT in the treatment of Steroid Refractory -Gastro-intestinal Acute GVHD (SR-GI-aGVHD) at D28 post inclusion [ Time Frame: up to 4 weeks post inclusion ]
    Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR)


Secondary Outcome Measures :
  1. Safety of FMT in patients with SR-GI-aGVHD [ Time Frame: through study completion, an average of six months ]
    The overall safety of the study will be evaluated with the incidence of all Adverse Events (AEs) and Serious Adverse Events (SAEs) (frequency, grade, relationship) throughout the study period

  2. Gastrointestinal GVHD overall response rate at D28 post inclusion [ Time Frame: Day 28 ]
    Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR) or Partial Response (PR)

  3. Number of patients with infectious disorders [ Time Frame: through study completion, an average of six months ]
    Evaluation of FMT activity on infectious disorders

  4. Number of multidrug resistant bacteria in faeces [ Time Frame: through study completion, an average of six months ]
    Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage

  5. Number of patients with Chronic GVHD [ Time Frame: through study completion, an average of six months ]
    Chronic GVHD expression


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359980


Locations
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France
CHU Amiens
Amiens, France, 80054
CHU Angers
Angers, France, 49933
CHRU Besançon
Besançon, France, 25030
Hôpital Henri Mondor
Créteil, France, 94000
CHRU Lille
Lille, France, 59037
CHU Limoges
Limoges, France, 87000
CHU Nantes
Nantes, France, 44000
Hôpital Saint Antoine
Paris, France, 75012
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69310
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France, 42270
CHU Strasbourg
Strasbourg, France, 67098
IUCT Oncopole
Toulouse, France, 31100
Italy
Gemelli Hospital
Roma, Italy, 168
Poland
Klinika Hematologii i Transplantologii
Gdańsk, Poland, 80-952
Public Clinic Hospital
Katowice, Poland, 40-032
University Clinical hospital
Wroclaw, Poland, 50-556
Sponsors and Collaborators
MaaT Pharma
Investigators
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Principal Investigator: Florent Malard, MD, PhD Hôpital Saint Antoine - PARIS
More Information
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Responsible Party: MaaT Pharma
ClinicalTrials.gov Identifier: NCT03359980    
Other Study ID Numbers: MPOH03
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No