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RECRUITING

NCT05762211

PHASE2

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

Sponsor: MaaT Pharma

View on ClinicalTrials.gov

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

Official title: A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

387

Start Date

2023-10-31

Completion Date

2027-02-15

Last Updated

2024-12-27

Healthy Volunteers

Conditions

Transplant Complication

Interventions

DRUG

Pooled allogeneic fecal microbiotherapy

Capsule for oral use

DRUG

Placebo

Capsule for oral use

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.

Locations (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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (54)