Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

Launched by MAAT PHARMA · Feb 27, 2023

Keywords

ClinConnect Summary

The PHOEBUS trial is a clinical study designed to test a treatment called MaaT033, which involves using stool from healthy donors to improve the health of patients undergoing a specific type of stem cell transplant known as allogeneic hematopoietic cell transplantation (alloHCT). The goal of this study is to see if this treatment can help prevent complications related to the transplant and ultimately improve survival for patients. This trial is currently looking for participants who are at least 50 years old and have certain blood cancers that make them eligible for this type of transplant.

To participate, patients must have a specific level of a type of white blood cell called neutrophils and should have received broad-spectrum antibiotics recently. It's also important that candidates have a sibling, unrelated, or family donor available for the transplant and are able to give their written consent to join the trial. If you join, you will be randomly assigned to receive either the treatment or a placebo (a substance with no active treatment). Throughout the study, participants will have regular check-ins to monitor their health. This trial will not include individuals with certain health issues or those who are pregnant, as these factors may complicate the results. If you think you might be eligible and are interested, you can discuss this with your healthcare provider.

Gender

ALL

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.