Informations générales (source: ClinicalTrials.gov)

NCT04935684 En recrutement
Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies (TMF-Allo)
Interventional
  • Leucémies
  • Lymphomes
  • Lymphome malin non hodgkinien
  • Syndromes myélodysplasiques
  • Syndrome
  • Leucémie chronique lymphocytaire à cellules B
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
décembre 2022
décembre 2027
29 juin 2024
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Necker-Enfants Malades Ambroise Marçais, MD Recrutement non commencé Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Département d'hématologie CAC Rouen - Rouen - France Anne-Lise Menard, MD Recrutement non commencé Contact (sur clinicalTrials)
Hématologie clinique CHU Besançon - Besançon - France Etienne Daguindau, MD Recrutement non commencé Contact (sur clinicalTrials)
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque - Pessac - France Carmen Botella Garcia, MD Recrutement non commencé Contact (sur clinicalTrials)
Hématologie clinique Institut de Cancérologie de la Loire - Saint-Étienne - France Emmanuelle Tavernier, MD Recrutement non commencé Contact (sur clinicalTrials)
IUC T - Oncopôle - Toulouse - France Anne Huynh, MD Recrutement non commencé Contact (sur clinicalTrials)
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand - Clermont-Ferrand - France Christian Dualé, MD, PhD En recrutement Contact (sur clinicalTrials)
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand - Clermont-Ferrand - France Jacques-Olivier Bay, MD, PhD Recrutement non commencé Contact (sur clinicalTrials)
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges - Limoges - France Pascal Turlure, MD Recrutement non commencé Contact (sur clinicalTrials)
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille - Lille - France David Beauvais, MD Recrutement non commencé Contact (sur clinicalTrials)
Service d'Hématologie Centre Hospitalier Lyon Sud - Lyon - France Marie-Virginie Larcher, MD Recrutement non commencé Contact (sur clinicalTrials)
Service d'Hématologie Clinique CHU Nantes - Nantes - France Patrice Chevallier, MD Recrutement non commencé Contact (sur clinicalTrials)
Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud - Amiens - France Magalie Magalie, MD Recrutement non commencé Contact (sur clinicalTrials)
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière - Paris - France Stéphanie Nguyen, MD, PhD Recrutement non commencé Contact (sur clinicalTrials)
Service d'hématologie clinique, département de greffe de moelle CHU Nice - Nice - France Michel Loschi, MD Recrutement non commencé Contact (sur clinicalTrials)
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy - Nancy - France Marie-Therese Rubio, MD Recrutement non commencé Contact (sur clinicalTrials)
Service d'hématologie greffe Hôpital St Louis - Paris - France Marie Robin, MD Recrutement non commencé Contact (sur clinicalTrials)
Service d'hématologie greffe Hôpital St Louis - Poitiers - France Deborah Desmier, MD Recrutement non commencé Contact (sur clinicalTrials)
Service hématologie CHU Grenoble - Grenoble - France Claude-Eric Bulabois, MD Recrutement non commencé Contact (sur clinicalTrials)
Service Maladies du sang CHU Angers - Angers - France Sylvie François, MD Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
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


- 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