Actively Recruiting
Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
Led by MaaT Pharma · Updated on 2024-12-27
387
Participants Needed
54
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosed with a hematologic malignancy requiring alloHCT with reduced toxicity or reduced intensity conditioning
- Neutrophil count (polynuclear neutrophils) greater than 0.5 G/L
- Received broad spectrum antibiotics within 90 days before inclusion
- Karnofsky performance status of 70% or more
- Availability of a sibling, unrelated, or familial haploidentical stem-cell donor
- Provided written informed consent
You will not qualify if you...
- Planned to receive non-myeloablative conditioning regimen (2 Gray total body irradiation +/- purine analog, fludarabine + cyclophosphamide or equivalent)
- Planned to receive conventional myeloablative conditioning regimen (e.g. high dose cyclophosphamide and high dose TBI ≥10Gy; high dose busulfan + high dose cyclophosphamide)
- Receiving a manipulated graft (in-vitro T-cell depletion)
- Planned to receive conditioning with alemtuzumab
- Planned alloHCT with cord blood cells
- Planned alloHCT from unrelated donor with ≥ 3/10 HLA-mismatches
- Receiving broad spectrum antibiotics at time of randomization
- Planned to receive vedolizumab or abatacept for GvHD prophylaxis
- Creatinine clearance less than 30 mL/min
- Liver abnormalities contra-indicating alloHCT
- Cardiac ejection fraction less than 40%
- Pulmonary impairment with lung carbon monoxide diffusing capacity (DLCO) less than 50%
- Pregnancy
- Confirmed or suspected intestinal ischemia
- Confirmed or suspected toxic megacolon or gastrointestinal perforation
- Gastro-intestinal surgery in the past 3 months
- Chronic digestive diseases (Crohn's disease, ulcerative colitis, inflammatory bowel disease, or other relevant conditions)
- Allergy or intolerance to trehalose or maltodextrin
- EBV-IgG negative serology
- Any condition interfering with study participation or posing significant risk
- Vulnerable patients unable to provide informed consent or in intensive care unit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 54 locations
1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Actively Recruiting
2
AZ Sint - Jan Brugge
Bruges, Belgium
Actively Recruiting
3
Institut Jules Bordet
Brussels, Belgium
Actively Recruiting
4
Universitair Ziekenhuis Brussel
Brussels, Belgium
Actively Recruiting
5
Universitair Ziekenhuis Gent
Ghent, Belgium
Actively Recruiting
6
Cliniques Universitaires Saint-Luc
Leuven, Belgium
Actively Recruiting
7
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, Belgium
Actively Recruiting
8
CHU Angers
Angers, France
Actively Recruiting
9
CHU Besançon
Besançon, France
Actively Recruiting
10
CHU Caen
Caen, France
Actively Recruiting
11
CHU Grenoble
La Tronche, France
Actively Recruiting
12
CHRU Lille
Lille, France
Actively Recruiting
13
Centre Hospitalier Universitaire Limoges
Limoges, France
Actively Recruiting
14
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
15
Hôpital Saint-Eloi
Montpellier, France
Actively Recruiting
16
CHU Nantes Hôtel Dieu
Nantes, France
Actively Recruiting
17
Hôpital l'Archet
Nice, France
Actively Recruiting
18
Hôpital Saint-Louis
Paris, France
Actively Recruiting
19
Hôpital St Antoine
Paris, France
Actively Recruiting
20
Hôpital Haut-Lévêque
Pessac, France
Actively Recruiting
21
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Not Yet Recruiting
22
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Actively Recruiting
23
CHU Rennes - Hôpital Pontchaillou
Rennes, France
Actively Recruiting
24
CHU St Etienne
Saint-Priest-en-Jarez, France
Actively Recruiting
25
IUCT Toulouse
Toulouse, France
Actively Recruiting
26
Centre Hospitalier Régional Universitaire de Tours
Tours, France
Not Yet Recruiting
27
CHU Tours
Tours, France
Actively Recruiting
28
Universitätsklinikum Augsburg
Augsburg, Germany
Actively Recruiting
29
Helios Klinikum Berlin-Buch
Berlin, Germany
Not Yet Recruiting
30
Universitätsklinikum Bonn
Bonn, Germany
Actively Recruiting
31
Universitätsklinikum Essen
Essen, Germany
Not Yet Recruiting
32
Universitätsklinikum Frankfurt
Frankfurt, Germany
Not Yet Recruiting
33
Universitätsklinikum des Saarlandes
Hombourg, Germany
Actively Recruiting
34
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany
Not Yet Recruiting
35
Universitätsklinikum Leipzig
Leipzig, Germany
Not Yet Recruiting
36
Universitätsmedizin Mannheim
Mannheim, Germany
Not Yet Recruiting
37
Klinikum rechts der Isar der Technischen Universität
München, Germany
Actively Recruiting
38
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
39
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Actively Recruiting
40
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
41
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
Actively Recruiting
42
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Spain
Actively Recruiting
43
Hospital Universitario Virgen de las Nieves
Granada, Spain
Actively Recruiting
44
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Actively Recruiting
45
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
46
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Spain
Actively Recruiting
47
Hospital General Universitario Morales Meseguer
Murcia, Spain
Actively Recruiting
48
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Actively Recruiting
49
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, Spain
Actively Recruiting
50
Hospital Universitario Marques de Valdecilla
Santander, Spain
Actively Recruiting
51
Hospital Universitario Virgen del Rocío
Seville, Spain
Actively Recruiting
52
Hospital Clínico Universitario de Valencia Avenida Blasco Ibáñez
Valencia, Spain
Actively Recruiting
53
Hospital Universitario La Fe
Valencia, Spain
Actively Recruiting
54
Cardiff and Vale University Health Board
Cardiff, United Kingdom
Actively Recruiting
Research Team
E
Emilie Plantamura, PharmD, PhD
CONTACT
R
Romain Collard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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