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

December 20, 2024 updated by: MaaT Pharma

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

387

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
      • Brugge, Belgium
        • Recruiting
        • AZ Sint - Jan Brugge
        • Contact:
          • Alexander Schauwvlieghe, MD
      • Brussel, Belgium
      • Brussel, Belgium
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
      • Gent, Belgium
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
      • Louvain, Belgium
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
      • Roeselare, Belgium
        • Recruiting
        • Algemeen Ziekenhuis Delta - Campus Rumbeke
        • Contact:
  • France
      • Angers, France
        • Recruiting
        • Chu Angers
        • Contact:
          • Sylvie François, MD
      • Besançon, France
        • Recruiting
        • CHU Besançon
        • Contact:
          • Etienne Daguindau, MD
      • Caen, France
        • Recruiting
        • CHU Caen
        • Contact:
          • Sylvain CHANTEPIE, MD
      • La Tronche, France
        • Recruiting
        • CHU Grenoble
        • Contact:
          • Martin Carré, MD
      • Lille, France
        • Recruiting
        • CHRU Lille
        • Contact:
          • Leonardo Magro, MD
      • Limoges, France
        • Recruiting
        • Centre Hospitalier Universitaire Limoges
        • Contact:
      • Marseille, France
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
          • Raynier Devillier
      • Montpellier, France
        • Recruiting
        • Hopital Saint-Eloi
        • Contact:
          • Ludovic Gabellier, MD
      • Nantes, France
        • Recruiting
        • CHU Nantes Hôtel Dieu
        • Contact:
          • Patrice Chevallier
      • Nice, France
        • Recruiting
        • Hôpital l'Archet
        • Contact:
          • Michael Loschi
      • Paris, France
        • Recruiting
        • Hopital St Antoine
        • Contact:
          • Florent Malard, MD, PhD
      • Paris, France
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
      • Pessac, France
        • Recruiting
        • Hôpital Haut-Lévêque
        • Contact:
          • Clémence Médiavilla
      • Pierre-Bénite, France
        • Not yet recruiting
        • Centre Hospitalier Lyon-Sud
        • Contact:
          • Hélène Labussiere-Wallet
      • Poitiers, France
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Contact:
      • Rennes, France
        • Recruiting
        • CHU Rennes - Hopital Pontchaillou
        • Contact:
          • Jean-Baptiste Méar, MD
      • Saint-Priest-en-Jarez, France
        • Recruiting
        • CHU St Etienne
        • Contact:
          • Jérôme Cornillon, MD
      • Toulouse, France
        • Recruiting
        • IUCT Toulouse
        • Contact:
          • Anne Huynh
      • Tours, France
        • Recruiting
        • CHU Tours
        • Contact:
          • Nicolas Vallet, MD
      • Tours, France
        • Not yet recruiting
        • Centre Hospitalier Régional Universitaire de Tours
        • Contact:
          • Nicolas Vallet
  • Germany
      • Augsburg, Germany
        • Recruiting
        • Universitätsklinikum Augsburg
        • Contact:
          • Christoph Schmid
      • Berlin, Germany
        • Not yet recruiting
        • HELIOS Klinikum Berlin-Buch
        • Contact:
          • Judith Niederland
      • Bonn, Germany
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
          • Tobias Holderried
      • Essen, Germany
        • Not yet recruiting
        • Universitätsklinikum Essen
        • Contact:
          • Thomas Schroeder
      • Frankfurt, Germany
        • Not yet recruiting
        • Universitätsklinikum Frankfurt
        • Contact:
          • Gesine Bug
      • Hombourg, Germany
        • Recruiting
        • Universitätsklinikum des Saarlandes
        • Contact:
      • Kiel, Germany
        • Not yet recruiting
        • Universitätsklinikum Schleswig-Holstein - Campus Kiel
        • Contact:
          • Friedrich Stölzel
      • Leipzig, Germany
        • Not yet recruiting
        • Universitätsklinikum Leipzig
        • Contact:
          • Madlen Jentzsch
      • Mannheim, Germany
        • Not yet recruiting
        • Universitätsmedizin Mannheim
        • Contact:
          • Daniela Heidenreich
      • München, Germany
        • Recruiting
        • Klinikum rechts der Isar der Technischen Universitat
        • Contact:
          • Mareike Verbeek, MD
      • Ulm, Germany
        • Recruiting
        • Universitätsklinikum Ulm
        • Contact:
          • Elisa Sala, MD
  • Netherlands
      • Groningen, Netherlands
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
          • Linde Morsink, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebrón
        • Contact:
          • Maria Sola Soto
      • Barcelona, Spain
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
          • Irene Garcia-Cadenas, MD
      • Barcelona, Spain
        • Recruiting
        • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
        • Contact:
          • Marta Peña Domingo
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
          • Manuel Jurado Chacon
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
          • Mi Kwon
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Karem Humala
      • Majadahonda, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro - Majadahonda
        • Contact:
          • Rafael Duarte Palomino
      • Murcia, Spain
        • Recruiting
        • Hospital General Universitario Morales Meseguer
        • Contact:
          • Oriana Jimena Lopez Godino
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra - Pamplona
        • Contact:
          • Jose Rifon, MD
      • Salamanca, Spain
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca - Hospital Clínico
        • Contact:
          • Lucia Lopez Corral, MD
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Maria Arancha Bermúdez
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Jose Antonio Perez Simon
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario La Fe
        • Contact:
          • Jaime Sanz Caballer
      • Valencia, Spain
        • Recruiting
        • Hospital Clínico Universitario de Valencia Avenida Blasco Ibáñez
        • Contact:
          • Rafael Hernani Morales, MD
  • United Kingdom
      • Cardiff, United Kingdom
        • Recruiting
        • Cardiff and Vale University Health Board
        • Contact:
          • Wendy Ingram, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral pooled fecal microbiotherapy - MaaT033
3 capsules per day
Drug: Pooled allogeneic fecal microbiotherapy
Capsule for oral use
Other Names:
  • MaaT033
Placebo Comparator: Placebo capsule
3 capsules per day
Drug: Placebo
Capsule for oral use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 12 months post alloHCT
To compare the efficacy of MaaT033 with its placebo on OS at 12 months after alloHCT
12 months post alloHCT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of gut microbiota diversity
Time Frame: 12 months post alloHCT
To evaluate MaaT033 efficacy in gut microbiota diversity restoration using alpha-diversity (Richness index)
12 months post alloHCT
grade 2-4 acute GvHD
Time Frame: 6 months post alloHCT
To evaluate the cumulative incidence of grade 2-4 acute GvHD within 6 months after alloHCT
6 months post alloHCT
grade 3-4 acute GvHD
Time Frame: 12 months post alloHCT

To evaluate the cumulative incidence of grade 3-4 severe acute GvHD within 12+

+ months after alloHCT
12 months post alloHCT
Non-relapse mortality
Time Frame: 12 months post alloHCT
To evaluate the cumulative incidence of non-relapse mortality within 12 months after alloHCT
12 months post alloHCT
Infectious-related mortality
Time Frame: 12 months post alloHCT
To evaluate the cumulative incidence of infectious-related mortality within 12 months after alloHCT
12 months post alloHCT
GvHD-related mortality
Time Frame: 12 months post alloHCT
To evaluate the cumulative incidence of GvHD-related mortality within 12 months after alloHCT
12 months post alloHCT
GRFS
Time Frame: 12 months post alloHCT
To evaluate GvHD-free relapse-free survival (GRFS) at 12 months after alloHCT
12 months post alloHCT
Quality of life questionnaire
Time Frame: 12 months post alloHCT
To evaluate the Quality of Life (EORTC QLQ C30 questionnaire)
12 months post alloHCT
Quality of life questionnaire
Time Frame: 12 months post alloHCT
To evaluate the Quality of Life (FACT-BMT questionnaire)
12 months post alloHCT
Proportion of patients with severe infections
Time Frame: 6 months after alloHCT
To evaluate the proportion of patients with severe infections defined by NCI-CTCAE ≥ Grade 3 within 6 months after alloHCT
6 months after alloHCT
Proportion of patients who have discontinued immune suppression therapies
Time Frame: 12 months after alloHCT
To evaluate the proportion of patients who have discontinued immune suppression therapies including standard of care GvHD prophylaxis and steroid treatment
12 months after alloHCT
Time to platelet engraftment
Time Frame: 12 months after alloHCT
Time to the first of 3 consecutive days of absolute neutrophil counts ≥ 0.5 G/L after alloHCT
12 months after alloHCT
Time to neutrophil engraftment
Time Frame: 12 months after alloHCT
Time to the first of 3 consecutive days of platelet counts ≥ 20 G/L after alloHCT
12 months after alloHCT
Safety: incidence of AEs
Time Frame: 12 months after alloHCT
To evaluate MaaT033 safety
12 months after alloHCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MaaT Pharma

Investigators

  • Principal Investigator: Florent Malard, MD, PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MPOH08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Transplant Complication

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe