Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation (TMF-Allo)

University Hospital, Clermont-Ferrand

Status and phase: Enrolling; Phase 2

Conditions: Hodgkin Lymphoma; Acute Leukemia in Remission; Myeloproliferative Syndrome; Chronic Lymphocytic Leukemia; Myeloma; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes

Treatments: Drug: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04935684

2020-000673-24 (EudraCT Number)

PHRC N 2018 BAY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group 1: Fecal Microbiota Transplantation (FMT)

Experimental group

Description:

Patients randomized in the "FMT group" will received FMT. FMT product will be made by the the pharmacy of the Clermont-Ferrand University Hospital from stools of healthy volunteer donors within 6 hours after defecation in order to preserve the viability of the bacteria. The preparation will be standardized: 50g aliquots will be prepared and diluted in 250mL of 0.9% NaCl containing 10% glycerol, until a homogeneous suspension is obtained. The preparation will be rapidly frozen at -80°C until use, with a maximum shelf life of 18 months.

Treatment:

Drug: Fecal Microbiota Transplantation

Group 2: no intervention

No Intervention group

Description:

The comparator group will be constituted by patients randomized in the "no FMT" group. For ethical reasons, these patients will not receive any FMT and therefore no enema or colic preparation. No placebo will be administered. Prophylactic anti-infective treatments can be introduced at any time.