SEARCHRCThematology, oncology

RCT·hematology, oncology, immunology, clinical trial, internal medicine·PMC10163541

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 · 9 authors, 6 centres

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TL;DR

This is a protocol for a randomized controlled trial testing if faecal microbiota transplantation (FMT) can improve outcomes for patients receiving an allogeneic stem cell transplant for blood cancers.

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This paper describes the protocol for a phase-II randomised controlled trial (the FMT-allo study) investigating faecal microbiota transplantation (FMT) to prevent complications after allogeneic haematopoietic stem-cell transplantation (allo-HSCT).

STUDY TYPE

RCT

SPECIALTY

hematology

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ORIGINAL PAPER

PMC10163541

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

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ABSTRACT

Abstract Introduction Allogeneic haematopoietic stem-cell transplantation (allo-HSCT) is a major treatment for many haematological malignancies. The procedure has a good success rate but high transplant-related toxicity (TRM). TRM is mostly related to graft-versus-host disease (GvHD) and infectious complications. Alterations of the intestinal microbiota plays a major role in the development of allo-HSCT complications. The gut microbiota could be restored by faecal microbiota transplantation (FMT). However, there are no published randomised studies assessing the efficacy of FMT for GvHD prophylaxis. Methods and analysis This prospective, open-label, multi-centre, parallel-group, randomised phase-II clinical trial has been designed to assess the effect of FMT on toxicity in patients treated with myeloablative allo-HSCT for haematological malignancy. Based on Fleming’s single-stage sample size estimation procedure, the design plans to include 60 male and female patients aged 18 or over per arm, to be randomly assigned to two groups, one with and one without (control group) FMT. The primary endpoint is GvHD-free relapse-free survival rate at 1 year after allo-HSCT. Secondary endpoints are outcome measures of the impact of FMT on allo-HSCT-related morbidity and mortality (overall survival and progression-free survival at 1 and 2 years, haematological parameters, infectious complications, tolerance and safety of FMT). The primary endpoint will be evaluated according to assumptions of the single-stage Fleming design, compared between groups by a log-rank test and further investigated in a multivariate marginal structural Cox model taking into account centre effect. The proportional-hazard hypothesis will be verified using Schoenfeld’s test and by plotting residuals. Ethics and dissemination The local institutional review board (CPP Sud-Est II, France) issued approval on 27 January 2021. The French national authorities issued approval on 15 April 2021. The outcome of the study will be disseminated via peer-reviewed publications and at congresses. Trial registration number NCT04935684 . Keywords: Bone marrow transplantation, Leukaemia, Lymphoma, Myeloma

CITATION EXPORT

Aurore Dougé, Aurélie Ravinet, Alexandrine Corriger et al.. 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). https://doi.org/10.1136/bmjopen-2022-068480

AUTHORS

9 · 6 CENTRES

Aurore Dougé, Aurélie Ravinet, Alexandrine Corriger, Aurélie Cabrespine, Mathieu Wasiak, Bruno Pereira, Harry Sokol, Stéphanie Nguyen, Jacques-Olivier Bay

1Service d'Oncologie Médicale, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
2Service de Thérapie Cellulaire et d’Hématologie Clinique Adulte, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
3Secteur Biométrie et Médico-économie, Direction de la Recherche Clinique et de l’Innovation, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
4Pôle Pharmacie, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
5Faculté de médecine, Sorbonne Université, Paris, France
6Service d’hématologie clinique, Hôpital de la Pitié-Salpêtrière AP-HP, Paris, France