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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
387

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 carre, 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
        • Hôpital 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
        • Hôpital 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 - Hôpital 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
        • Universitatsklinikum 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
        • Universitatsklinikum des Saarlandes
        • Contact:
      • Kiel, Germany
        • Not yet recruiting
        • Universitätsklinikum Schleswig-Holstein - Campus Kiel
        • Contact:
          • Friedrich Stölzel
      • Leipzig, Germany
        • Not yet recruiting
        • Universitatsklinikum Leipzig
        • Contact:
          • Madlen Jentzsch
      • Mannheim, Germany
        • Not yet recruiting
        • Universitätsmedizin Mannheim
        • Contact:
          • Daniela Heidenreich
      • München, Germany
        • Recruiting
        • Klinikum rechts der Isar der Technischen Universität
        • 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'Hebron
        • 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 Rocío
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MaaT Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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