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Transplant ComplicationPhase 2NCT05762211

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

A Phase 2 study testing Pooled allogeneic fecal microbiotherapy in people with Transplant Complication, run by MaaT Pharma at 54 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Transplant Complication
What is being tested?
Pooled allogeneic fecal microbiotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
387 participants
Where
54 sitesin 6 countries
Study dates
31 Oct 2023to 15 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

54 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Emilie Plantamura, PharmD, PhD contact

0033 663590186

eplantamura@maat-pharma.com

Romain Collard contact

rcollard@maat-pharma.com

54 sites in 6 countries

France20 sites, 20 recruiting

  • CHU Angers

    Angers

    Sylvie François, MD

    Recruiting

  • CHU Besançon

    Besançon

    Etienne Daguindau, MD

    Recruiting

  • CHU Caen

    Caen

    Sylvain Chantepie, MD

    Recruiting

  • CHU Grenoble

    La Tronche

    Martin Carré, MD

    Recruiting

  • CHRU Lille

    Lille

    Leonardo MAGRO, MD

    Recruiting

  • Centre Hospitalier Universitaire Limoges

    Limoges

    Pascal Turlure, MD, 0033 5 55 05 89 75, pascal.turlure@chu-limoges.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Raynier Devillier

    Recruiting

  • Hôpital Saint-Eloi

    Montpellier

    Ludovic Gabellier, MD

    Recruiting

  • CHU Nantes Hôtel Dieu

    Nantes

    Patrice Chevallier

    Recruiting

  • Hôpital l'Archet

    Nice

    Michael Loschi

    Recruiting

  • Hôpital Saint-Louis

    Paris

    David Michonneau, MD, 0033 1 42 49 96 39, david.michonneau@aphp.fr

    Recruiting

  • Hôpital St Antoine

    Paris

    Florent Malard, MD, PhD

    Recruiting

  • Hôpital Haut-Lévêque

    Pessac

    Clémence Médiavilla

    Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite

    Hélène Labussiere-Wallet

    Not yet recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers

    Déborah Desmier, MD, 0033 549444307, Deborah.DESMIER@chu-poitiers.fr

    Recruiting

  • CHU Rennes - Hôpital Pontchaillou

    Rennes

    Jean-Baptiste Méar, MD

    Recruiting

  • CHU St Etienne

    Saint-Priest-en-Jarez

    Jérôme Cornillon, MD

    Recruiting

  • IUCT Toulouse

    Toulouse

    Anne Huynh

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours

    Tours

    Nicolas Vallet

    Not yet recruiting

  • CHU Tours

    Tours

    Nicolas Vallet, MD

    Recruiting

Other trials in France

Spain14 sites, 14 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Irene Garcia-Cadenas, MD

    Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona

    Maria Sola Soto

    Recruiting

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

    Barcelona

    Marta Peña Domingo

    Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada

    Manuel Jurado Chacon

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid

    Mi Kwon

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Karem Humala

    Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda

    Rafael Duarte Palomino

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia

    Oriana Jimena Lopez Godino

    Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona

    Jose Rifon, MD

    Recruiting

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca

    Lucia Lopez Corral, MD

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander

    Maria Arancha Bermúdez

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville

    Jose Antonio Perez Simon

    Recruiting

  • Hospital Clínico Universitario de Valencia Avenida Blasco Ibáñez

    Valencia

    Rafael Hernani Morales, MD

    Recruiting

  • Hospital Universitario La Fe

    Valencia

    Jaime Sanz Caballer

    Recruiting

Other trials in Spain

Germany11 sites, 11 recruiting

  • Universitätsklinikum Augsburg

    Augsburg

    Christoph Schmid

    Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin

    Judith Niederland

    Not yet recruiting

  • Universitätsklinikum Bonn

    Bonn

    Tobias Holderried

    Recruiting

  • Universitätsklinikum Essen

    Essen

    Thomas Schroeder

    Not yet recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt

    Gesine Bug

    Not yet recruiting

  • Universitätsklinikum des Saarlandes

    Hombourg

    Sarah Altmeyer, MD, sarah.altmeyer@uks.eu

    Recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel

    Friedrich Stölzel

    Not yet recruiting

  • Universitätsklinikum Leipzig

    Leipzig

    Madlen Jentzsch

    Not yet recruiting

  • Universitätsmedizin Mannheim

    Mannheim

    Daniela Heidenreich

    Not yet recruiting

  • Klinikum rechts der Isar der Technischen Universität

    München

    Mareike Verbeek, MD

    Recruiting

  • Universitätsklinikum Ulm

    Ulm

    Elisa Sala, MD

    Recruiting

Other trials in Germany

Belgium7 sites, 7 recruiting

  • Universitair Ziekenhuis Antwerpen

    Antwerp

    Anke Verlinden, MD, +32 3 821 39 19, anke.verlinden@uza.be

    Recruiting

  • AZ Sint - Jan Brugge

    Bruges

    Alexander Schauwvlieghe, MD

    Recruiting

  • Institut Jules Bordet

    Brussels

    Fabio Andreozzi, MD, 02/555.36.60, fabio.andreozzi@hubruxelles.be

    Recruiting

  • Universitair Ziekenhuis Brussel

    Brussels

    Ann De Becker, MD, 02/477 6040, Ann.DeBecker@uzbrussel.be

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent

    Anke Delie, MD, 09 3322125, anke.delie@ugent.be

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Leuven

    Xavier Poiré, MD, 02 764 18 00, xavier.poire@uclouvain.be

    Recruiting

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Roeselare

    Dries Deeren, MD, 051 23 73 22, Dries.Deeren@azdelta.be

    Recruiting

Other trials in Belgium

Netherlands1 site, 1 recruiting

  • Universitair Medisch Centrum Groningen

    Groningen

    Linde Morsink, MD

    Recruiting

Other trials in Netherlands

United Kingdom1 site, 1 recruiting

  • Cardiff and Vale University Health Board

    Cardiff

    Wendy Ingram, MD

    Recruiting

Other trials in United Kingdom

About this study

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)

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

Being tested
Pooled allogeneic fecal microbiotherapy, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pooled allogeneic fecal microbiotherapyDrug

    Also called MaaT033

    Capsule for oral use

  • PlaceboDrug

    Capsule for oral use

Study groups in NCT05762211
Study groupRoleWhat they receive
Oral pooled fecal microbiotherapy - MaaT033Experimental3 capsules per day
Receives: Drug: Pooled allogeneic fecal microbiotherapy
Placebo capsulePlacebo comparator3 capsules per day
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    To compare the efficacy of MaaT033 with its placebo on OS at 12 months after alloHCT

    Measured: 12 months post alloHCT

Secondary outcomes (14)

  1. Restoration of gut microbiota diversity

    To evaluate MaaT033 efficacy in gut microbiota diversity restoration using alpha-diversity (Richness index)

    Measured: 12 months post alloHCT

  2. grade 2-4 acute GvHD

    To evaluate the cumulative incidence of grade 2-4 acute GvHD within 6 months after alloHCT

    Measured: 6 months post alloHCT

  3. grade 3-4 acute GvHD

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

    + months after alloHCT

    Measured: 12 months post alloHCT

  4. Non-relapse mortality

    To evaluate the cumulative incidence of non-relapse mortality within 12 months after alloHCT

    Measured: 12 months post alloHCT

  5. Infectious-related mortality

    To evaluate the cumulative incidence of infectious-related mortality within 12 months after alloHCT

    Measured: 12 months post alloHCT

  6. GvHD-related mortality

    To evaluate the cumulative incidence of GvHD-related mortality within 12 months after alloHCT

    Measured: 12 months post alloHCT

  7. GRFS

    To evaluate GvHD-free relapse-free survival (GRFS) at 12 months after alloHCT

    Measured: 12 months post alloHCT

  8. Quality of life questionnaire

    To evaluate the Quality of Life (EORTC QLQ C30 questionnaire)

    Measured: 12 months post alloHCT

  9. Quality of life questionnaire

    To evaluate the Quality of Life (FACT-BMT questionnaire)

    Measured: 12 months post alloHCT

  10. Proportion of patients with severe infections

    To evaluate the proportion of patients with severe infections defined by NCI-CTCAE ≥ Grade 3 within 6 months after alloHCT

    Measured: 6 months after alloHCT

  11. Proportion of patients who have discontinued immune suppression therapies

    To evaluate the proportion of patients who have discontinued immune suppression therapies including standard of care GvHD prophylaxis and steroid treatment

    Measured: 12 months after alloHCT

  12. Time to platelet engraftment

    Time to the first of 3 consecutive days of absolute neutrophil counts ≥ 0.5 G/L after alloHCT

    Measured: 12 months after alloHCT

  13. Time to neutrophil engraftment

    Time to the first of 3 consecutive days of platelet counts ≥ 20 G/L after alloHCT

    Measured: 12 months after alloHCT

  14. Safety: incidence of AEs

    To evaluate MaaT033 safety

    Measured: 12 months after alloHCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start31 Oct 2023
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
387 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05762211
Sponsor's protocol ID
MPOH08
Status last verified
Dec 2024
First submitted
27 Jan 2023
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pooled allogeneic fecal microbiotherapy in people with Transplant Complication, run by MaaT Pharma at 54 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in France, Spain, Germany, Belgium, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilie Plantamura, PharmD, PhD (0033 663590186, eplantamura@maat-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 12 months post alloHCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05762211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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