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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Transplant Complication

In brief

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

Key facts

Study ID

NCT05762211

Run by

MaaT Pharma

People needed

387

Starts

2023-10-31

Expected to finish

2027-02-15

Last updated by the study team

2024-12-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (enrolling)
• Institut Jules Bordet — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)
• AZ Sint - Jan Brugge — Bruges, Belgium (enrolling)
• Cliniques Universitaires Saint-Luc — Leuven, Belgium (enrolling)
• Algemeen Ziekenhuis Delta - Campus Rumbeke — Roeselare, Belgium (enrolling)
• CHU Angers — Angers, France (enrolling)
• CHU Besançon — Besançon, France (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• CHU Grenoble — La Tronche, France (enrolling)
• CHRU Lille — Lille, France (enrolling)
• Centre Hospitalier Universitaire Limoges — Limoges, France (enrolling)
• Institut Paoli Calmettes — Marseille, France (enrolling)
• Hôpital Saint-Eloi — Montpellier, France (enrolling)
• CHU Nantes Hôtel Dieu — Nantes, France (enrolling)
• Hôpital l'Archet — Nice, France (enrolling)
• Hôpital Saint-Louis — Paris, France (enrolling)
• Hôpital St Antoine — Paris, France (enrolling)
• Hôpital Haut-Lévêque — Pessac, France (enrolling)
• CHU Caen — Caen, France (enrolling)
• Centre Hospitalier Universitaire de Poitiers — Poitiers, France (enrolling)
• CHU Rennes - Hôpital Pontchaillou — Rennes, France (enrolling)
• CHU St Etienne — Saint-Priest-en-Jarez, France (enrolling)
• IUCT Toulouse — Toulouse, France (enrolling)
• CHU Tours — Tours, France (enrolling)

Full record on ClinicalTrials.gov

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