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Clinical Trials in the UK / NCT05762211
Recruiting Phase 2

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

NCT05762211 · tracked via the Priya Life Science UK tracker
Sponsor
MaaT Pharma
Phase
Phase 2
Started
2023-10-31
Last updated
2024-12-27

Condition(s) studied

Transplant Complication

Investigational drug(s) / intervention(s)

Pooled allogeneic fecal microbiotherapyPlacebo

Pooled allogeneic fecal microbiotherapy: Capsule for oral use

Placebo: Capsule for oral use

Study 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

Eligibility

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Universitair Ziekenhuis Antwerpen Antwerp Belgium Recruiting
AZ Sint - Jan Brugge Bruges Belgium Recruiting
Institut Jules Bordet Brussels Belgium Recruiting
Universitair Ziekenhuis Brussel Brussels Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
Cliniques Universitaires Saint-Luc Leuven Belgium Recruiting
Algemeen Ziekenhuis Delta - Campus Rumbeke Roeselare Belgium Recruiting
CHU Angers Angers France Recruiting
CHU Besançon Besançon France Recruiting
CHU Caen Caen France Recruiting
CHU Grenoble La Tronche France Recruiting
CHRU Lille Lille France Recruiting
Centre Hospitalier Universitaire Limoges Limoges France Recruiting
Institut Paoli Calmettes Marseille France Recruiting
Hôpital Saint-Eloi Montpellier France Recruiting
CHU Nantes Hôtel Dieu Nantes France Recruiting
Hôpital l'Archet Nice France Recruiting
Hôpital Saint-Louis Paris France Recruiting
Hôpital St Antoine Paris France Recruiting
Hôpital Haut-Lévêque Pessac France Recruiting
Centre Hospitalier Lyon-Sud Pierre-Bénite France Not Yet Recruiting
Centre Hospitalier Universitaire de Poitiers Poitiers France Recruiting
CHU Rennes - Hôpital Pontchaillou Rennes France Recruiting
CHU St Etienne Saint-Priest-en-Jarez France Recruiting
IUCT Toulouse Toulouse France Recruiting
Centre Hospitalier Régional Universitaire de Tours Tours France Not Yet Recruiting
CHU Tours Tours France Recruiting
Universitätsklinikum Augsburg Augsburg Germany Recruiting
Helios Klinikum Berlin-Buch Berlin Germany Not Yet Recruiting
Universitätsklinikum Bonn Bonn Germany Recruiting
Universitätsklinikum Essen Essen Germany Not Yet Recruiting
Universitätsklinikum Frankfurt Frankfurt Germany Not Yet Recruiting
Universitätsklinikum des Saarlandes Hombourg Germany Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel Germany Not Yet Recruiting
Universitätsklinikum Leipzig Leipzig Germany Not Yet Recruiting
Universitätsmedizin Mannheim Mannheim Germany Not Yet Recruiting
Klinikum rechts der Isar der Technischen Universität München Germany Recruiting
Universitätsklinikum Ulm Ulm Germany Recruiting
Universitair Medisch Centrum Groningen Groningen Netherlands Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Spain Recruiting

+ 14 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05762211 on ClinicalTrials.gov ↗ ← All trials in the UK