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