Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
NCT ID: NCT05762211
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
387 participants
INTERVENTIONAL
2023-10-31
2027-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Oral pooled fecal microbiotherapy - MaaT033
3 capsules per day
Pooled allogeneic fecal microbiotherapy
Capsule for oral use
Placebo capsule
3 capsules per day
Placebo
Capsule for oral use
Interventions
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Pooled allogeneic fecal microbiotherapy
Capsule for oral use
Placebo
Capsule for oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
50 Years
ALL
No
Sponsors
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MaaT Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Florent Malard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
AZ Sint - Jan Brugge
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Cliniques Universitaires Saint-Luc
Leuven, , Belgium
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, , Belgium
CHU Angers
Angers, , France
CHU Besançon
Besançon, , France
CHU Caen
Caen, , France
CHU Grenoble
La Tronche, , France
CHRU Lille
Lille, , France
Centre Hospitalier Universitaire Limoges
Limoges, , France
Institut Paoli Calmettes
Marseille, , France
Hôpital Saint-Eloi
Montpellier, , France
CHU Nantes Hôtel Dieu
Nantes, , France
Hôpital l'Archet
Nice, , France
Hôpital Saint-Louis
Paris, , France
Hôpital St Antoine
Paris, , France
Hôpital Haut-Lévêque
Pessac, , France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
CHU Rennes - Hôpital Pontchaillou
Rennes, , France
CHU St Etienne
Saint-Priest-en-Jarez, , France
IUCT Toulouse
Toulouse, , France
Centre Hospitalier Régional Universitaire de Tours
Tours, , France
CHU Tours
Tours, , France
Universitätsklinikum Augsburg
Augsburg, , Germany
Helios Klinikum Berlin-Buch
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum des Saarlandes
Hombourg, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Klinikum rechts der Isar der Technischen Universität
München, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, , Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Clínico Universitario de Valencia Avenida Blasco Ibáñez
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Cardiff and Vale University Health Board
Cardiff, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Anke Verlinden, MD
Role: primary
Alexander Schauwvlieghe, MD
Role: primary
Fabio Andreozzi, MD
Role: primary
Ann De Becker, MD
Role: primary
Anke Delie, MD
Role: primary
Xavier Poiré, MD
Role: primary
Dries Deeren, MD
Role: primary
Sylvie François, MD
Role: primary
Etienne Daguindau, MD
Role: primary
Sylvain Chantepie, MD
Role: primary
Martin Carré, MD
Role: primary
Leonardo MAGRO, MD
Role: primary
Pascal Turlure, MD
Role: primary
Raynier Devillier
Role: primary
Ludovic Gabellier, MD
Role: primary
Patrice Chevallier
Role: primary
Michael Loschi
Role: primary
David Michonneau, MD
Role: primary
Florent Malard, MD, PhD
Role: primary
Clémence Médiavilla
Role: primary
Hélène Labussiere-Wallet
Role: primary
Déborah Desmier, MD
Role: primary
Jean-Baptiste Méar, MD
Role: primary
Jérôme Cornillon, MD
Role: primary
Anne Huynh
Role: primary
Nicolas Vallet
Role: primary
Nicolas Vallet, MD
Role: primary
Christoph Schmid
Role: primary
Judith Niederland
Role: primary
Tobias Holderried
Role: primary
Thomas Schroeder
Role: primary
Gesine Bug
Role: primary
Sarah Altmeyer, MD
Role: primary
Friedrich Stölzel
Role: primary
Madlen Jentzsch
Role: primary
Daniela Heidenreich
Role: primary
Mareike Verbeek, MD
Role: primary
Elisa Sala, MD
Role: primary
Linde Morsink, MD
Role: primary
Irene Garcia-Cadenas, MD
Role: primary
Maria Sola Soto
Role: primary
Marta Peña Domingo
Role: primary
Manuel Jurado Chacon
Role: primary
Mi Kwon
Role: primary
Karem Humala
Role: primary
Rafael Duarte Palomino
Role: primary
Oriana Jimena Lopez Godino
Role: primary
Jose Rifon, MD
Role: primary
Lucia Lopez Corral, MD
Role: primary
Maria Arancha Bermúdez
Role: primary
Jose Antonio Perez Simon
Role: primary
Rafael Hernani Morales, MD
Role: primary
Jaime Sanz Caballer
Role: primary
Wendy Ingram, MD
Role: primary
Other Identifiers
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MPOH08
Identifier Type: -
Identifier Source: org_study_id