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

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ClinicalTrials.gov Identifier: NCT03359980
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: treated patients
Treated with Fecal Microbiota Transfer (FMT)
Drug: fecal microbiota transfer
transfer of fecal microbiota from healthy donor to the patients




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

  3. 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

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



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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 3 or 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
  • Late onset aGVHD
  • 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 109 /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 or latex
  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Corentin Le Camus, PhD 0699027114 clecamus@maat-pharma.com
Contact: Emilie Plantamura, PharmD, PhD 0663590186 eplantamura@maat-pharma.com

Locations
France
Hôpital Saint Antoine Recruiting
Paris, France, 75012
Contact: Florent Malard, MD, PhD         
Principal Investigator: Florent Malard, MD, PhD         
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Contact: Xavier Thomas, MD         
Principal Investigator: Xavier Thomas, MD         
Sponsors and Collaborators
MaaT Pharma
Investigators
Principal Investigator: Florent Malard Hôpital Saint Antoine - PARIS

Responsible Party: MaaT Pharma
ClinicalTrials.gov Identifier: NCT03359980     History of Changes
Other Study ID Numbers: MPOH03
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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