Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal Microbiota Transplantation.
- Who it may be relevant to
- Registry conditions: Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome, Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
Overview
The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD). The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.
Detailed description
The TMF-Allo study is a prospective, open-label, multi-center, parallel, randomized phase II clinical trial comparing a group patients with FMT and a control group of patients without FMT.
The main objective of this study is to assess the effect of allogeneic FMT versus no treatment on Graft-versus-host disease and Relapse-Free Survival (GRFS) at one year in adult patients treating with myelo-ablative allo-HSCT for haematologic malignancy.
The secondary objectives are to evaluate :
* Overall survival, progression-free survival at 1 and 2 years, * The haematological evolution, * The evolution of infections, * The tolerance and safety of the TMF carried out in post-transplant, * The evolution of the composition and diversity of the microbiota in allograft patients receiving TMF or not.
Interventions
- Drug Fecal Microbiota Transplantation
Patients randomized in the "FMT group" will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT
Primary outcome measures
- Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation [Time frame: at Day 360 after allogeneic hematopoietic stem cell transplantation]
Secondary outcome measures (12)
- Overall survival [Time frame: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]
- Progression-free survival [Time frame: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]
- Haematopoietic reconstitution [Time frame: At the time of haematopoietic reconstitution]
- Engraftment rates [Time frame: At Day 30, Day 60, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantationday]
- Cumulative incidence of acute GvHD [Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation]
- Cumulative incidence of chronic GvHD [Time frame: At Day 720 after allogeneic hematopoietic stem cell transplantation]
- Transplant-Related Mortality [Time frame: At Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]
- Cumulative incidence of infections [Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation]
- Severe infections description [Time frame: From the day of inclusion to Day 360 after allogeneic hematopoietic stem cell transplantation]
- Impact of Fecal Microbiota Transplantation (FMT) on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection [Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation]
- Unexpected event description that could be in relation with FMT of Fecal Microbiota Transplantation (FMT) [Time frame: From the day of FMT to Day 360 after allogeneic hematopoietic stem cell transplantation]
- Quality of life assessment [Time frame: at Day -7, Day 30, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation]
Eligibility criteria
Inclusion criteria
- Patient aged 18 or over
- Men and women
- Patients affiliated with a social-security organization
- Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood)
- Signed and dated informed consent
Exclusion criteria
- Status of tumor progression at the time of allo-HSCT
- Inability to understand the protocol (linguistic barrier, cognitive difficulties)
- Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)
- Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)
- Fecal incontinence
- Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication.
- Pregnant women
- Patient under guardianship, curatorship or protection of justice
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 20 centers
- Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud — Amiens
- Service Maladies du sang CHU Angers — Angers
- Hématologie clinique CHU Besançon — Besançon
- Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU G — Clermont-Ferrand
- Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Fer — Clermont-Ferrand
- Service hématologie CHU Grenoble — Grenoble
- Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille — Lille
- Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges — Limoges
- … and 12 more centers
Publications
- Douge A, Ravinet A, Corriger A, Cabrespine A, Wasiak M, Pereira B, Sokol H, Nguyen S, Bay JO. Faecal microbiota transplantation to prevent complications after allogeneic stem cell transplantation for haematological malignancies: a study protocol for a randomised controlled phase-II trial (the FMT-allo study). BMJ Open. 2023 May 2;13(5):e068480. doi: 10.1136/bmjopen-2022-068480. PMID 37130682
Identifiers
NCT: NCT04935684 · PHRC N 2018 BAY · 2020-000673-24