[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MaaT Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},387,"ESTIMATED","INTERVENTIONAL",[23],"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",[26],"Transplant Complication","RECRUITING","2024-12-20",{"date":30,"type":31},"2024-12-27","ACTUAL",{"date":33,"type":31},"2023-10-31",{"date":35,"type":20},"2027-02-15",{"name":37,"class":38},"MaaT Pharma","INDUSTRY",54,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":4,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":57,"locationsCount":58},"100421523","early-access-program-with-maat013-in-steroid-refractory-acute-gastrointestinal-graft-versus-host-disease-100421523","NCT04768907","Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease","ATLAS","Inclusion Criteria:\n\n* Age \\> or = 18\n* Grade III-IV gastro intestinal acute graft versus host disease with or without involvement of other organs:\n* patients resistant to corticosteroid (CS) and resistant to one or multiple lines of treatments\n* patients who cannot tolerate CS tapering, i.e., begin of CS at 2.0 mg\u002Fkg\u002Fd, demonstrate response, but show disease progress before a 50% decrease from the initial starting dose of CS is achieved.\n* acute GVHD with overlap syndrome\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Relapsed\u002Fpersistent malignancy requiring rapid immune suppression withdrawal\n* Current or past veno-occlusive disease or other uncontrolled complication\n* Absolute neutrophil count \\\u003C500\u002FµL for 3 consecutive days. Use of growth factor supplementation is allowed\n* Absolute platelet count \\\u003C 10 000\u002FµL. Use of platelet infusion is allowed\n* Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation\n* Known allergy or intolerance to trehalose or maltodextrin\n* Pregnancy\n* Breastfeeding","18 Years","EXPANDED_ACCESS","MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned.\n\nIn the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.",[51,52],"Acute Graft Versus Host Disease in Intestine","Steroid Refractory GVHD","AVAILABLE","2024-08-27",{"date":56,"type":31},"2024-08-28",{"name":37,"class":38},46,""]