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

Last updated: December 20, 2024
Sponsor: MaaT Pharma
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Pooled allogeneic fecal microbiotherapy

Placebo

Clinical Study ID

NCT05762211
MPOH08
  • Ages > 50
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 50 years old

  • Presence of a hematologic malignancy for which an alloHCT is indicated with areduced 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 toinclusion

  • Karnofsky index ≥ 70%

  • Availability of a sibling donor, an unrelated stem-cell donor or a familialhaploidentical donor

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Patients planned to receive a non-myeloablative conditioning regimen (2 Gray totalbody irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide orequivalent)

  • 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/kgIV) + 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 tophysician'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 fullparticipation in the study, including administration of study drug and attendingrequired study visits; pose a significant risk to the subject; or interfere withinterpretation of study data.

  • Vulnerable patients such as: persons deprived of liberty, persons in Intensive CareUnit unable to provide informed consent prior to the intervention.

Study Design

Total Participants: 387
Treatment Group(s): 2
Primary Treatment: Pooled allogeneic fecal microbiotherapy
Phase: 2
Study Start date:
October 31, 2023
Estimated Completion Date:
February 15, 2027

Connect with a study center

  • Universitair Ziekenhuis Antwerpen

    Antwerpen,
    Belgium

    Active - Recruiting

  • AZ Sint - Jan Brugge

    Brugge,
    Belgium

    Active - Recruiting

  • Institut Jules Bordet

    Brussel,
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Brussel

    Brussel,
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent,
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc

    Louvain,
    Belgium

    Active - Recruiting

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Roeselare,
    Belgium

    Active - Recruiting

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • CHU Besançon

    Besançon,
    France

    Active - Recruiting

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • CHU Grenoble

    La Tronche,
    France

    Active - Recruiting

  • CHRU Lille

    Lille,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Limoges

    Limoges,
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille,
    France

    Active - Recruiting

  • Hôpital Saint-Eloi

    Montpellier,
    France

    Active - Recruiting

  • CHU Nantes Hôtel Dieu

    Nantes,
    France

    Active - Recruiting

  • Hôpital l'Archet

    Nice,
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris,
    France

    Active - Recruiting

  • Hôpital St Antoine

    Paris,
    France

    Active - Recruiting

  • Hôpital Haut-Lévêque

    Pessac,
    France

    Active - Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers,
    France

    Active - Recruiting

  • CHU Rennes - Hôpital Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • CHU St Etienne

    Saint-Priest-en-Jarez,
    France

    Active - Recruiting

  • IUCT Toulouse

    Toulouse,
    France

    Active - Recruiting

  • CHU Tours

    Tours,
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Tours

    Tours,
    France

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg,
    Germany

    Active - Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn,
    Germany

    Active - Recruiting

  • Universitätsklinikum Essen

    Essen,
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Universitätsklinikum des Saarlandes

    Hombourg,
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel,
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig,
    Germany

    Site Not Available

  • Universitätsmedizin Mannheim

    Mannheim,
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität

    München,
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm,
    Germany

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada,
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda,
    Spain

    Active - Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia,
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona,
    Spain

    Active - Recruiting

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca,
    Spain

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia Avenida Blasco Ibáñez

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Universitario La Fe

    Valencia,
    Spain

    Active - Recruiting

  • Cardiff and Vale University Health Board

    Cardiff,
    United Kingdom

    Active - Recruiting

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