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Clinical Trials in France / NCT04935684
Recruiting Phase 2

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

NCT04935684 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Clermont-Ferrand
Phase
Phase 2
Started
2022-12-20
Last updated
2026-09-21

Condition(s) studied

Acute Leukemia in RemissionMyelodysplastic SyndromesMyeloproliferative SyndromeHodgkin LymphomaLymphoma, Non-HodgkinMyelomaChronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

Fecal Microbiota Transplantation →

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. The enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation — at Day 360 after allogeneic hematopoietic stem cell transplantation
    GRFS is a composite endpoint of GvHD-free/relapse-free survival in which events include grade II-IV acute GvHD, moderate and severe chronic GvHD, relapse, or death in the first year post-HSCT. GRFS will be measured at one year after allo-HSCT and compared between both groups of patients.

Trial sites (20)

FacilityCityRegionStatus
Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud Amiens France Not Yet Recruiting
Service Maladies du sang CHU Angers Angers France Not Yet Recruiting
Hématologie clinique CHU Besançon Besançon France Not Yet Recruiting
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand Clermont-Ferrand France Recruiting
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand Clermont-Ferrand France Not Yet Recruiting
Service hématologie CHU Grenoble Grenoble France Not Yet Recruiting
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille Lille France Not Yet Recruiting
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges Limoges France Recruiting
Service d'Hématologie Centre Hospitalier Lyon Sud Lyon France Not Yet Recruiting
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy Nancy France Not Yet Recruiting
Service d'Hématologie Clinique CHU Nantes Nantes France Not Yet Recruiting
Service d'hématologie clinique, département de greffe de moelle CHU Nice Nice France Not Yet Recruiting
Service d'Hématologie Adultes Hôpital Necker Paris France Recruiting
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière Paris France Not Yet Recruiting
Service d'hématologie greffe Hôpital St Louis Paris France Not Yet Recruiting
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque Pessac France Not Yet Recruiting
Service d'hématologie greffe Hôpital St Louis Poitiers France Not Yet Recruiting
Département d'hématologie CAC Rouen Rouen France Not Yet Recruiting
Hématologie clinique Institut de Cancérologie de la Loire Saint-Etienne France Not Yet Recruiting
IUC T - Oncopôle Toulouse France Not Yet Recruiting

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Other trials for the same condition

Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia Recruiting
Biocollection in MyeloDysplastic Syndrome (P-MDS) Recruiting
Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years). Active, not recruiting
A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) Active, not recruiting
Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04935684 on ClinicalTrials.gov ↗ ← All trials in France