NCT05762211 Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
| NCT ID | NCT05762211 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | MaaT Pharma |
| Condition | Transplant Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 387 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 387 participants in total. It began in 2023-10-31 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Florent Malard, MD, PhD
PRINCIPAL INVESTIGATOR
APHP
Frequently Asked Questions
Who can join the NCT05762211 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Transplant Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05762211 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05762211 currently recruiting?
Yes, NCT05762211 is actively recruiting participants. Contact the research team at eplantamura@maat-pharma.com for enrollment information.
Where is the NCT05762211 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Bruges, Belgium, Brussels, Belgium, Brussels, Belgium and 11 additional locations.
Who is sponsoring the NCT05762211 clinical trial?
NCT05762211 is sponsored by MaaT Pharma. The principal investigator is Florent Malard, MD, PhD at APHP. The trial plans to enroll 387 participants.