Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
1 other identifier
interventional
387
6 countries
54
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2023
Typical duration for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
December 27, 2024
December 1, 2024
3 years
January 27, 2023
December 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
To compare the efficacy of MaaT033 with its placebo on OS at 12 months after alloHCT
12 months post alloHCT
Secondary Outcomes (14)
Restoration of gut microbiota diversity
12 months post alloHCT
grade 2-4 acute GvHD
6 months post alloHCT
grade 3-4 acute GvHD
12 months post alloHCT
Non-relapse mortality
12 months post alloHCT
Infectious-related mortality
12 months post alloHCT
- +9 more secondary outcomes
Study Arms (2)
Oral pooled fecal microbiotherapy - MaaT033
EXPERIMENTAL3 capsules per day
Placebo capsule
PLACEBO COMPARATOR3 capsules per day
Interventions
Capsule for oral use
Eligibility Criteria
You may qualify if:
- 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
- Karnofsky index ≥ 70%
- Availability of a sibling donor, an unrelated stem-cell donor or a familial haploidentical donor
- Written informed consent
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MaaT Pharmalead
Study Sites (54)
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
Study Officials
- PRINCIPAL INVESTIGATOR
Florent Malard, MD, PhD
APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2023
First Posted
March 9, 2023
Study Start
October 31, 2023
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
February 15, 2027
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share