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Kingdom","UK",{"type":53,"coordinates":640},[641,642],-3.18,51.48,{"lat":642,"lon":641},[645],{"name":646,"role":39,"phone":30,"phoneExt":30,"email":30},"Wendy Ingram, MD",{"type":648,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100497820","phase-2-oral-pooled-fecal-microbiotherapy-to-prevent-allogeneic-hematopoietic-cell-transplantation-complications-phoebus-trial-100497820",false,"NCT05762211","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)","Inclusion Criteria:\n\n* Age ≥ 50 years old\n* Presence of a hematologic malignancy for which an alloHCT is indicated with a reduced toxicity or reduced intensity conditioning regimen\n* Patients with polynuclear neutrophils \\> 0.5 G\u002FL\n* Patients having received wide spectrum antibiotics within the last 90 days prior to inclusion\n* Karnofsky index ≥ 70%\n* Availability of a sibling donor, an unrelated stem-cell donor or a familial haploidentical donor\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +\u002F- purine analog, fludarabine + cyclophosphamide or equivalent)\n* 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\u002Fkg IV) + high dose cyclophosphamide)\n* Patients receiving a manipulated graft (in-vitro T-cell depletion)\n* Patients planned to receive a conditioning regimen with alemtuzumab\n* Patients planned to receive alloHCT with cord blood cells\n* Patients planned to receive alloHCT from unrelated donor with \\>= 3\u002F10 HLA-mismatches\n* Patients receiving a large spectrum antibiotic at time of randomization\n* Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis\n* Creatinine clearance \\\u003C30 mL\u002Fmin\n* Bilirubin or amino-transferases abnormalities contra-indicating alloHCT\n* Cardiac ejection fraction less than 40%\n* Pulmonary impairment with \\\u003C50% lung carbon monoxide diffusing capacity (DLCO)\n* Pregnancy\n* Confirmed or suspected intestinal ischemia\n* Confirmed or suspected toxic megacolon or gastrointestinal perforation\n* Any history of gastro-intestinal surgery in the past 3 months\n* Any history of chronic digestive disease (Crohn's disease, ulcerative colitis, inflammatory bowel disease or other relevant digestive condition according to physician's judgement)\n* Known allergy or intolerance to trehalose or maltodextrin\n* Patients with EBV-IgG negative serology\n* 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.\n* Vulnerable patients such as: persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.","ALL","50 Years",{"count":659,"type":660},387,"ESTIMATED","INTERVENTIONAL",[663],"PHASE2","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",[666],"Transplant Complication","2024-12-20",{"date":669,"type":670},"2024-12-27","ACTUAL",{"date":672,"type":670},"2023-10-31",{"date":674,"type":660},"2027-02-15",{"name":5,"class":6},54]