RecruitingPhase 2NCT05762211
Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
Sponsor
MaaT Pharma
Enrollment
387 participants
Start Date
Oct 31, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 50 Years
Inclusion Criteria7
- 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 Criteria21
- 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.
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Interventions
DRUGPooled allogeneic fecal microbiotherapy
Capsule for oral use
DRUGPlacebo
Capsule for oral use
Locations(54)
View Full Details on ClinicalTrials.gov
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NCT05762211
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