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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 : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE December 2, 2017
Last Update Posted Date January 21, 2019
Actual Study Start Date  ICMJE August 13, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
Efficacy of FMT in the treatment of 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)
Change History Complete list of historical versions of study NCT03359980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
  • 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
  • Number of patients with infectious disorders [ Time Frame: through study completion, an average of six months ]
    Evaluation of FMT activity on infectious disorders
  • 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
  • Number of patients with Chronic GVHD [ Time Frame: through study completion, an average of six months ]
    Chronic GVHD expression
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
  • 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 AEs and SAEs (frequency, grade, relationship) throughout the study period
  • Number of patients with infectious disorders [ Time Frame: through study completion, an average of six months ]
    Evaluation of FMT activity on infectious disorders
  • Number of multidrug resistant bacteria in faeces [ Time Frame: through study completion, an average of six months ]
    Evaluation of FMT activity on MDRB carriage
  • Number of patients with Chronic GVHD [ Time Frame: through study completion, an average of six months ]
    Chronic GVHD expression
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
Official Title  ICMJE Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Fecal Microbiota Transplantation
Intervention  ICMJE Drug: fecal microbiota transfer
transfer of fecal microbiota from healthy donor to the patients
Study Arms  ICMJE Experimental: treated patients
Treated with Fecal Microbiota Transfer (FMT)
Intervention: Drug: fecal microbiota transfer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Corentin Le Camus, PhD 0699027114 clecamus@maat-pharma.com
Contact: Emilie Plantamura, PharmD, PhD 0663590186 eplantamura@maat-pharma.com
Listed Location Countries  ICMJE France,   Italy,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03359980
Other Study ID Numbers  ICMJE MPOH03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MaaT Pharma
Study Sponsor  ICMJE MaaT Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Florent Malard Hôpital Saint Antoine - PARIS
PRS Account MaaT Pharma
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP