Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
165
Countries
1
Sites
20
Patient who underwent Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for various haematological malignancies
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
Key facts
- Sponsor
- CHU Gabriel-Montpied
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 2 May 2022 → ongoing
- Decision date (initial)
- 2024-11-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- French Ministry of Health
External identifiers
- EU CT number
- 2024-512969-14-01
- EudraCT number
- 2020-000673-24
- ClinicalTrials.gov
- NCT04935684
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
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
Secondary objectives 3
- 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
Conditions and MedDRA coding
Patient who underwent Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for various haematological malignancies
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-512969-14-00 | Fecal Microbiota Transplantation in the prevention of complications after allogeneic hematopoietic stem cell transplantation for hematologic malignancy | CHU Gabriel-Montpied |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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
- With myelo-ablative type conditioning
- With an allogeneic peripheral stem cell transplant, regardless of the type of donor (except cord blood)
Exclusion criteria 6
- Patient with tumor progression status at the time of allo-HSCT
- History of another progressive cancer or one occurring in the previous 3 years (excluding basal cell carcinoma)
- Faecal incontinence
- Allograft of HSC from bone marrow
- Patient suffering from a serious and uncontrolled concomitant condition (severe cardiac, renal, hepatic or respiratory failure, serious sepsis)
- Patient under guardianship, curatorship or safeguard of justice
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- GRFS (Graft-versus-host disease and Relapse-Free Survival) rate at 1 year post-allograft.
Secondary endpoints 7
- Survival at 1 and 2 years (overall and progression-free)
- Evaluation of hematological criteria
- Assessment of GVHD
- Incidence of infectious complications
- Tolerance and safety of post-allo-HSCT FMT
- Evolution of the composition and diversity of the microbiota
- Quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11668413 · Product
- Active substance
- Allogeneic Faecal Microbiota
- Pharmaceutical form
- RECTAL SUSPENSION
- Route of administration
- RECTAL USE
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 250 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CHU CLERMONT FERRAND
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHU Gabriel-Montpied
- Sponsor organisation
- CHU Gabriel-Montpied
- Address
- 58 Rue Montalembert
- City
- Clermont Ferrand
- Postcode
- 63000
- Country
- France
Scientific contact point
- Organisation
- CHU Gabriel-Montpied
- Contact name
- Lise laclautre
Public contact point
- Organisation
- CHU Gabriel-Montpied
- Contact name
- Lise laclautre
Locations
1 EU/EEA country · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 165 | 20 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Hématologie adulte, 149 Rue De Sevres, 75015, Paris
Besancon University Hospital Center
Hématologie clinique, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Nice
Hématologie clinique, département de greffe de moelle, 151 Route De Saint Antoine, 06200, Nice
Centre Henri Becquerel
Unité de Recherche Clinique, Rue D Amiens, 76038, Rouen Cedex
Centre Hospitalier Universitaire De Nantes
Hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Hématologie greffe, 1 Avenue Claude Vellefaux, 75010, Paris
Hospices Civils De Lyon
Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Poitiers
Onco-Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
University Hospital Of Clermont-Ferrand
Plateforme d’Investigation Clinique, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospitalier Universitaire Grenoble Alpes
Hématologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Hématologie et de Thérapie Cellulaire, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Lille
Maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire Amiens Picardie
Hématologie Clinique et Thérapie Cellulaire, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire D'Angers
Maladies du sang, 4 Rue Larrey, 49100, Angers
University Hospital Of Clermont-Ferrand
Thérapie Cellulaire et d’Hématologie Clinique Adulte, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire De Saint Etienne
Recherche Clinique, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Toulouse
Oncopole, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
CHRU De Nancy
Hématologie, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Et Universitaire De Limoges
Hématologie Clinique et Thérapie Cellulaire, 2 Avenue Martin Luther King, 87000, Limoges
Assistance Publique Hopitaux De Paris
Hématologie clinique, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2022-05-02 | 2022-05-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512969-14-01 | 8 |
| Protocol (for publication) | D1_Protocol_2024-512969-14-01_TC | 8 |
| Protocol (for publication) | D1_Protocol-signature_2024-512969-14-01 | 8 |
| Recruitment arrangements (for publication) | 2020-000673-24_RECRUTEMENT-donneur_TMF-Allo | 2 |
| Recruitment arrangements (for publication) | 2020-000673-24_RECRUTEMENT-patient_TMF-Allo | 1 |
| Recruitment arrangements (for publication) | K1_RECRUITMENT ARRANGEMENTS_TMF-Allo | 1 |
| Subject information and informed consent form (for publication) | 2024-512969-14-00_NICE-donneur_TMF-Allo | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient_TC | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ FR_2024-512969-14-01 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-512969-14-01_TC | 7 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-18 | France | Acceptable 2024-11-08
|
2024-11-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-08 | France | Acceptable 2025-05-21
|
2025-05-21 |