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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorMaaT Pharma

About this 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pooled allogeneic fecal microbiotherapy
  • Placebo

Treatment groups

387 Participants
are divided into 2 treatment groups

Sponsors and collaborators