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
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
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
Parallel
Pooled allogeneic fecal microbiotherapy
DrugCapsule for oral use
Placebo
DrugCapsule for oral use
Overall survival
To compare the efficacy of MaaT033 with its placebo on OS at 12 months after alloHCT
Restoration of gut microbiota diversity
To evaluate MaaT033 efficacy in gut microbiota diversity restoration using alpha-diversity (Richness index)
grade 2-4 acute GvHD
To evaluate the cumulative incidence of grade 2-4 acute GvHD within 6 months after alloHCT
grade 3-4 acute GvHD
To evaluate the cumulative incidence of grade 3-4 severe acute GvHD within 12+ \+ months after alloHCT
Non-relapse mortality
To evaluate the cumulative incidence of non-relapse mortality within 12 months after alloHCT
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