Clinical trial • Phase II • Oncology|Haematology

Allogeneic faecal microbiota for Haematological malignancy|Post-allogeneic haematopoietic stem cell transplantation

Phase II trial of Allogeneic faecal microbiota for Haematological malignancy|Post-allogeneic haematopoietic stem cell transplantation.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Haematological malignancy|Post-allogeneic haematopoietic stem cell transplantation
Trial Stage
Phase II
Drug Modality
Other

Key dates

Initial CTIS Submission Date
18-10-2024
First CTIS Authorization Date
18-11-2024

Trial design

No treatment (control arm: no treatment) Phase II trial in France.

Comparator
No treatment (control arm: no treatment)
Target Sample Size
165
Trial Duration For Participant
365

Eligibility

Recruits 165 Patients under guardianship, curatorship or safeguard of justice are excluded (Exclusion criterion: 'Patient under guardianship, curatorship or safeguard of justice'); informed consent must be signed by participants (Inclusion criterion: 'Patients who had signed informed consent'). No paediatric assent/consent procedures are described..

Vulnerable Population
Patients under guardianship, curatorship or safeguard of justice are excluded (Exclusion criterion: 'Patient under guardianship, curatorship or safeguard of justice'); informed consent must be signed by participants (Inclusion criterion: 'Patients who had signed informed consent'). No paediatric assent/consent procedures are described.

Inclusion criteria

  • {"criterion_text":"- Patients who underwent allo-HSCT for a controlled haematological malignancy"}
  • {"criterion_text":"- Patients aged ≥ 18 years old"}
  • {"criterion_text":"- Patients affiliated with a social security organization"}
  • {"criterion_text":"- Patients who had signed informed consent"}
  • {"criterion_text":"- With myelo-ablative type conditioning"}
  • {"criterion_text":"- With an allogeneic peripheral stem cell transplant, regardless of the type of donor (except cord blood)"}

Exclusion criteria

  • {"criterion_text":"- Patient with tumor progression status at the time of allo-HSCT"}
  • {"criterion_text":"- History of another progressive cancer or one occurring in the previous 3 years (excluding basal cell carcinoma)"}
  • {"criterion_text":"- Faecal incontinence"}
  • {"criterion_text":"- Allograft of HSC from bone marrow"}
  • {"criterion_text":"- Patient suffering from a serious and uncontrolled concomitant condition (severe cardiac, renal, hepatic or respiratory failure, serious sepsis)"}
  • {"criterion_text":"- Patient under guardianship, curatorship or safeguard of justice"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- GRFS (Graft-versus-host disease and Relapse-Free Survival) rate at 1 year post-allograft.","definition_or_measurement_approach":"Rate at 1 year post-allograft; GRFS defined as graft-versus-host disease-free and relapse-free survival (GvHD-free/Relapse-free Survival) measured at 1 year post-transplant."}

Secondary endpoints

  • {"endpoint_text":"- Survival at 1 and 2 years (overall and progression-free)","definition_or_measurement_approach":"Overall survival and progression-free survival measured at 1 and 2 years."}
  • {"endpoint_text":"- Evaluation of hematological criteria","definition_or_measurement_approach":"Assessment of predefined hematological criteria (not further specified in provided source)."}
  • {"endpoint_text":"- Assessment of GVHD","definition_or_measurement_approach":"Assessment of acute and chronic graft-versus-host disease incidence/severity (method not further specified in provided source)."}
  • {"endpoint_text":"- Incidence of infectious complications","definition_or_measurement_approach":"Measurement of incidence of infections post-transplant (including severe infections); specific definitions not provided in source."}
  • {"endpoint_text":"- Tolerance and safety of post-allo-HSCT FMT","definition_or_measurement_approach":"Safety and tolerability assessments of fecal microbiota transplantation post-allo-HSCT (specific safety measures not detailed in provided source)."}
  • {"endpoint_text":"- Evolution of the composition and diversity of the microbiota","definition_or_measurement_approach":"Microbiota composition and diversity assessed by 16S sequencing at predefined timepoints (before allo-HSCT, before FMT, and at M1, M3 and M12) including donor samples."}
  • {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Quality of life assessed by patient-reported measures (specific instrument not detailed in provided source)."}

Recruitment

Planned Sample Size
165
Recruitment Window Months
96
Consent Approach
Informed consent must be signed by participants (Inclusion criterion: 'Patients who had signed informed consent'). Participants are adults (≥18). Subject information and informed consent form documents are listed in the submission (e.g. 'L1_SIS and ICF patient'); French-language materials appear available (translations and French documents present). No paediatric assent/consent process described.

Geography

Total Number Of Sites
20
Total Number Of Participants
165

France

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
21-05-2025
Processing Time Days
208
Number Of Sites
20
Number Of Participants
165

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hématologie Clinique et Thérapie Cellulaire
Contact Person Name
Pascal TURLURE
Contact Person Email
pascal.turlure@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Onco-Hématologie et Thérapie Cellulaire
Contact Person Name
Deborah Desmier
Site Name
CHRU De Nancy
Department Name
Hématologie
Contact Person Name
Marie-Thérèse RUBIO
Contact Person Email
M.RUBIO@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Recherche Clinique
Contact Person Name
Emmanuelle Tavernier
Site Name
Besancon University Hospital Center
Department Name
Hématologie clinique
Contact Person Name
Etienne DAGUINDAU
Contact Person Email
etienne.daguindau@gmail.com
Site Name
Centre Henri Becquerel
Department Name
Unité de Recherche Clinique
Contact Person Name
Anne-Lise Ménard
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hématologie et de Thérapie Cellulaire
Contact Person Name
Carmen Botella-Garcia
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Thérapie Cellulaire et d’Hématologie Clinique Adulte
Contact Person Name
Jacques-Olivier BAY
Contact Person Email
jobay@chu-clermontferrand.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hématologie adulte
Contact Person Name
Ambroise Marcais
Contact Person Email
ambroise.marcais@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hématologie clinique, département de greffe de moelle
Contact Person Name
Michel Loschi
Contact Person Email
loschi.m@chu-nice.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris Cedex 13)
Department Name
Hématologie clinique
Contact Person Name
Stéphanie Nguyen
Contact Person Email
stephanie.nguyen@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (1 Avenue Claude Vellefaux)
Department Name
Hématologie greffe
Contact Person Name
Marie Robin
Contact Person Email
marie.robin@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Hématologie
Contact Person Name
Claude-Eric BULABOIS
Contact Person Email
CEBulabois@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Maladies du sang
Contact Person Name
David BEAUVAIS
Contact Person Email
david.beauvais@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Oncopole
Contact Person Name
Anne Huynh
Contact Person Email
huynh.anne@iuct-oncopole.fr
Site Name
University Hospital Of Clermont-Ferrand (Clermont Ferrand Cedex 1)
Department Name
Plateforme d’Investigation Clinique
Contact Person Name
Christian Duale
Contact Person Email
cduale@chu-clermontferrand.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hématologie
Contact Person Name
Patrice Chevallier
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Maladies du sang
Contact Person Name
Sylvie François
Contact Person Email
SyFrancois@chu-angers.fr
Site Name
Hospices Civils De Lyon
Department Name
Hématologie
Contact Person Name
Marie-Virginie LARCHER
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hématologie Clinique et Thérapie Cellulaire
Contact Person Name
Magalie Joris
Contact Person Email
magali.joris@chu-amiens.fr

Sponsor

Primary sponsor

Full Name
CHU Gabriel-Montpied
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Third parties

  • {"country":"","full_name":"French Ministry of Health","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Transplant microbiote fécal
Active Substance
Allogeneic faecal microbiota
Modality
Other
Routes Of Administration
RECTAL USE
Route
RECTAL USE
Maximum Dose
250 ml

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