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Recruiting NCT05762211

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

Phase II Interventional Transplant Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pooled allogeneic fecal microbiotherapy, Placebo.
Who it may be relevant to
Registry conditions: Transplant Complication. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France, Germany, Netherlands, Spain +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

Interventions

  • Drug Pooled allogeneic fecal microbiotherapy
    Capsule for oral use
  • Drug Placebo
    Capsule for oral use

Primary outcome measures

  • Overall survival [Time frame: 12 months post alloHCT]
Secondary outcome measures (12)
  • Restoration of gut microbiota diversity [Time frame: 12 months post alloHCT]
  • grade 2-4 acute GvHD [Time frame: 6 months post alloHCT]
  • grade 3-4 acute GvHD [Time frame: 12 months post alloHCT]
  • Non-relapse mortality [Time frame: 12 months post alloHCT]
  • Infectious-related mortality [Time frame: 12 months post alloHCT]
  • GvHD-related mortality [Time frame: 12 months post alloHCT]
  • GRFS [Time frame: 12 months post alloHCT]
  • Quality of life questionnaire [Time frame: 12 months post alloHCT]
  • Quality of life questionnaire [Time frame: 12 months post alloHCT]
  • Proportion of patients with severe infections [Time frame: 6 months after alloHCT]
  • Proportion of patients who have discontinued immune suppression therapies [Time frame: 12 months after alloHCT]
  • Time to platelet engraftment [Time frame: 12 months after alloHCT]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

France · 20 centers
  • CHU Angers — Angers
  • CHU Besançon — Besançon
  • CHU Caen — Caen
  • CHU Grenoble — La Tronche
  • CHRU Lille — Lille
  • Centre Hospitalier Universitaire Limoges — Limoges
  • Institut Paoli Calmettes — Marseille
  • Hôpital Saint-Eloi — Montpellier
  • … and 12 more centers
Spain · 14 centers
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • Hospital Universitari Vall d'Hebrón — Barcelona
  • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet) — Barcelona
  • Hospital Universitario Virgen de las Nieves — Granada
  • Hospital General Universitario Gregorio Marañón — Madrid
  • Hospital Universitario La Paz — Madrid
  • Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda
  • Hospital General Universitario Morales Meseguer — Murcia
  • … and 6 more centers
Germany · 11 centers
  • Universitätsklinikum Augsburg — Augsburg
  • Helios Klinikum Berlin-Buch — Berlin
  • Universitätsklinikum Bonn — Bonn
  • Universitätsklinikum Essen — Essen
  • Universitätsklinikum Frankfurt — Frankfurt
  • Universitätsklinikum des Saarlandes — Hombourg
  • Universitätsklinikum Schleswig-Holstein - Campus Kiel — Kiel
  • Universitätsklinikum Leipzig — Leipzig
  • … and 3 more centers
Belgium · 7 centers
  • Universitair Ziekenhuis Antwerpen — Antwerp
  • AZ Sint - Jan Brugge — Bruges
  • Institut Jules Bordet — Brussels
  • Universitair Ziekenhuis Brussel — Brussels
  • Universitair Ziekenhuis Gent — Ghent
  • Cliniques Universitaires Saint-Luc — Leuven
  • Algemeen Ziekenhuis Delta - Campus Rumbeke — Roeselare
Netherlands · 1 center
  • Universitair Medisch Centrum Groningen — Groningen
United Kingdom · 1 center
  • Cardiff and Vale University Health Board — Cardiff

Identifiers

NCT: NCT05762211 · MPOH08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗