Informations générales (source: ClinicalTrials.gov)
A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
Interventional
Phase 2
MaaT Pharma (Voir sur ClinicalTrials)
octobre 2023
février 2027
05 avril 2025
This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the
activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of
transplant-related complications in eligible alloHCT patients
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Cristina CASTILLA-LLORENTE | 30/04/2026 13:45:06 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Saint Antoine | Florent Malard, MD, PhD | 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 | |||||
| Centre Hospitalier Lyon-Sud - Pierre-Bénite - France | Hélène Labussiere-Wallet | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Régional Universitaire de Tours - Tours - France | Nicolas Vallet | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Poitiers - Poitiers - France | Déborah Desmier, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Limoges - Limoges - France | Pascal Turlure, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille - Lille - France | Leonardo MAGRO, MD | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | Sylvie François, MD | Contact (sur clinicalTrials) | |||
| CHU Besançon - Besançon - France | Etienne Daguindau, MD | Contact (sur clinicalTrials) | |||
| CHU Caen - Caen - France | Sylvain Chantepie, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble - La Tronche - France | Martin Carré, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes Hôtel Dieu - Nantes - France | Patrice Chevallier | Contact (sur clinicalTrials) | |||
| CHU Rennes - Hôpital Pontchaillou - Rennes - France | Jean-Baptiste Méar, MD | Contact (sur clinicalTrials) | |||
| CHU St Etienne - Saint-Priest-en-Jarez - France | Jérôme Cornillon, MD | Contact (sur clinicalTrials) | |||
| CHU Tours - Tours - France | Nicolas Vallet, MD | Contact (sur clinicalTrials) | |||
| Hôpital Haut-Lévêque - Pessac - France | Clémence Médiavilla | Contact (sur clinicalTrials) | |||
| Hôpital l'Archet - Nice - France | Michael Loschi | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Eloi - Montpellier - France | Ludovic Gabellier, MD | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis - Paris - France | David Michonneau, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Raynier Devillier | Contact (sur clinicalTrials) | |||
| IUCT Toulouse - Toulouse - France | Anne Huynh | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age ≥ 50 years old
- Presence of a hematologic malignancy for which an alloHCT is indicated with a
reduced toxicity or reduced intensity conditioning regimen
- Patients with polynuclear neutrophils > 0.5 G/L
- Patients having received wide spectrum antibiotics within the last 90 days prior to
inclusion
- Karnofsky index ≥ 70%
- Availability of a sibling donor, an unrelated stem-cell donor or a familial
haploidentical donor
- Written informed consent
- Age ≥ 50 years old
- Presence of a hematologic malignancy for which an alloHCT is indicated with a
reduced toxicity or reduced intensity conditioning regimen
- Patients with polynuclear neutrophils > 0.5 G/L
- Patients having received wide spectrum antibiotics within the last 90 days prior to
inclusion
- Karnofsky index ≥ 70%
- Availability of a sibling donor, an unrelated stem-cell donor or a familial
haploidentical donor
- Written informed consent
- Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total
body irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide or
equivalent)
- Patients planned to receive a conventional myeloablative conditioning regimen (e.g.
high dose cyclophosphamide and high dose TBI (≥10Gy); high dose busulfan (12.8 mg/kg
IV) + high dose cyclophosphamide)
- Patients receiving a manipulated graft (in-vitro T-cell depletion)
- Patients planned to receive a conditioning regimen with alemtuzumab
- Patients planned to receive alloHCT with cord blood cells
- Patients planned to receive alloHCT from unrelated donor with >= 3/10 HLA-mismatches
- Patients receiving a large spectrum antibiotic at time of randomization
- Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis
- Creatinine clearance <30 mL/min
- Bilirubin or amino-transferases abnormalities contra-indicating alloHCT
- Cardiac ejection fraction less than 40%
- Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
- Pregnancy
- Confirmed or suspected intestinal ischemia
- Confirmed or suspected toxic megacolon or gastrointestinal perforation
- Any history of gastro-intestinal surgery in the past 3 months
- Any history of chronic digestive disease (Crohn's disease, ulcerative colitis,
inflammatory bowel disease or other relevant digestive condition according to
physician's judgement)
- Known allergy or intolerance to trehalose or maltodextrin
- Patients with EBV-IgG negative serology
- Any condition that would, in the investigator's judgment, interfere with full
participation in the study, including administration of study drug and attending
required study visits; pose a significant risk to the subject; or interfere with
interpretation of study data.
- Vulnerable patients such as: persons deprived of liberty, persons in Intensive Care
Unit unable to provide informed consent prior to the intervention.