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    The EU Clinical Trials Register currently displays   44201   clinical trials with a EudraCT protocol, of which   7332   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-000673-24
    Sponsor's Protocol Code Number:PHRC_N_2018_BAY
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-000673-24
    A.3Full title of the trial
    Faecal microbiota transplantation for prevention of graft-versus-host sisease after allogeneic stem cell transplantation for haematological malignancies
    Transplantation de Microbiote Fécal dans la prévention de la réaction du greffon contre l’hôte après allogreffe de cellules souches hématopoïétiques pour une hémopathie maligne.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Faecal microbiota transplantation for prevention of complications after allogeneic stem cell transplantation for blood cancers
    Transplantation fécale en prévention des complications post-allogreffe de cellules souches pour les cancers du sang
    A.3.2Name or abbreviated title of the trial where available
    TMF-allo
    TMF-allo
    A.4.1Sponsor's protocol code numberPHRC_N_2018_BAY
    A.5.4Other Identifiers
    Name:NANumber:NA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Clermont-Ferrand
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFrench Ministry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointDirection de la Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number3347354963
    B.5.5Fax number3347354730
    B.5.6E-mailpromo_interne_drci@chu-clermontferrand.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFecal Microbiota Transplantation
    D.3.4Pharmaceutical form Concentrate for rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient who underwent Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for various haematological malignancies. Faecal microbiota transplantation (FMT) will be assessed to prevent allogeneic complications such as graft-versus-host disease (GvHD) and infection which remain a major cause of morbidity, mortality, and impaired quality of life. During the conditioning regimen and after the allo-HSCT, many treatments can negatively impact microbiota homeostasis.
    E.1.1.1Medical condition in easily understood language
    Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for malignant hemopathy to prevent post-allogeneic complications such as graft versus host disease and infections.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of allogeneic FMT compared with no treatment on graft-versus-host disease-free, relapse-free survival (GRFS) at one year post-transplant in patients treated with myeloablative conditioning (MAC) allo-HSCT for haematological malignancy.
    E.2.2Secondary objectives of the trial
    • To evaluate incidence of engraftment, incidence of aGvHD and cGvHD, overall survival, progression-free survival, transplant-related mortality, quality of life, rate of severe infections.
    • To evaluate the tolerance and safety of post-allo-HSCT FMT, its effect on multidrug-resistant bacteria/extended spectrum beta-lactamases (ESBL), the cumulative incidence of clostridium difficile infection and diarrhoea.
    • To evaluate microbiota composition and diversity by 16s sequencing prospectively in all patients (treatment group and control group) before allo-HSCT, before FMT and at M1, M3 and M12, and in donors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients who underwent allo-HSCT for a controlled haematological malignancy.
    • Patients aged ≥ 18 years old.
    • Patients affiliated with a social security organization.
    • Patients who had signed informed consent.
    • Allo-HSCT procedure: MAC followed by a granulocyte-colony stimulating factor mobilized-peripheral HSC graft infusion.
    • Any HSCT donor, except cord blood.
    E.4Principal exclusion criteria
    • Medical history of another progressive uncontrolled cancer within the previous three years.
    • Presence of a simultaneous serious and uncontrolled disease.
    • Faecal incontinence.
    E.5 End points
    E.5.1Primary end point(s)
    Graft-versus-host disease-free, relapse-free survival (GRFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    E.5.2Secondary end point(s)
    - Incidence of engraftment
    - Incidence of aGvHD
    - Incidence of cGvHD
    - Overall survival
    - Progression-free survival
    - Transplant-related mortality
    - Quality of life
    - Rate of severe infections
    - Tolerance and safety of post-allo-HSCT FMT
    - Effect on multidrug-resistant bacteria/extended spectrum beta-lactamases (ESBL)
    - Cumulative incidence of clostridium difficile infection and diarrhoea
    - Microbiota composition and diversity by 16s sequencing prospectively in all patients (treatment group and control group) and in donors.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Rate of engraftment at day 100
    - Cumulative incidence of grade II-IV acute GvHD at 1 year
    - Cumulative incidence of chronic GvHD at 2 years
    - Overall survival and progression-free survival at 1 and 2 years
    - Transplant related mortality at six months, 1 and 2 years.
    - Quality of life at inclusion, M1, M3, M6, M12 and M24.
    - Cumulative incidence of infectious disease at 1 year
    - Tolerance and safety after allo-HSCT
    - Effect on multidrug-resistant bacteria and ESBL at 1 year
    - Cumulative incidence of clostridium difficile infection at 1 year
    - Cumulative incidence of diarrhoea at 6 months
    - Microbiota composition and diversity assessed by 16s sequencing performed prospectively in all patients (before allo-HSCT, before FMT, and at M1, M3 and M12 post FMT) and in donors

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned23
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    An independent data monitoring committee is planned. This committee will convene at study start-up and then as and when needed throughout the study, at its own initiative or at the request of the sponsor, to analyse safety data. It will have a consultative role on any move to stop the trial prematurely for toxicity. This committee includes a haematologist, a pharmacist, and a biostatistician not participating in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 150
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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