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New treatment option for Transplant Complication
Official title Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
ClinicalTrials.gov ID: NCT05762211
What this study is testing
What is Pooled allogeneic fecal microbiotherapy?
Pooled allogeneic fecal microbiotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for transplant complication.
Also referred to as MaaT033.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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%
You likely can't join if
- Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine analog, fludarabine +...
- Patients planned to receive a conventional myeloablative conditioning regimen (e.g. high dose cyclophosphamide and high dose TBI (≥10Gy); high dose...
- 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
See the full eligibility 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
- 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...
- Vulnerable patients such as: persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Belgium
- Bruges, Belgium
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Angers, France
- Besançon, France
- Caen, France
- La Tronche, France
- Lille, France
- Limoges, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Paris, France
- Pessac, France
- Pierre-Bénite, France
- Poitiers, France
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Belgium; Bruges, Belgium; Brussels, Belgium; Ghent, Belgium; Leuven, Belgium; Roeselare, Belgium and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.