Status:
WITHDRAWN
Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD
Lead Sponsor:
Leland Metheny
Conditions:
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD)
Eligibility:
All Genders
19-74 years
Phase:
PHASE2
Brief Summary
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. You are being asked to take part in this study...
Eligibility Criteria
Inclusion
- One of the following diagnosis:
- High risk aGVHD (either biopsy proven or clinical diagnosed) (see Appendix B \& C) as defined by either:
- Lower gastrointestinal (GI) stage 3+
- Hyper-acute GVHD as defined by aGVHD of the GI tract within the first 14 days of transplant AND
- Subjects with treatment-naive acute GVHD as defined as those who have not received previous systemic treatment for acute GVHD, except for a maximum of 7 days of no less than 1 mg/kg/day of methyl-prednisolone (or equivalent dose of prednisone).
- OR:
- Steroid refractory aGVHD of the GI tract (either biopsy proven or clinical diagnosed) as defined by:
- no response to steroid treatment (minimum daily dose: 2 mg/kg methyl-prednisolone or equivalent) lasting at least 7 days, or
- progression of at least one grade within the first 72 h of treatment
- ECOG Performance status \< 3
- Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source.
- Patients who are able stop prophylactic antibiotics during the treatment period
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Active malignancy
- Patients with any concurrent uncontrolled clinically significant medical condition including active infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
- Pregnant or breastfeeding women
- 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.
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
- Patients with any severe gastrointestinal condition other than GI-GVHD.
- Inability (e.g. dysphagia) to or unwilling to swallow capsules
- Active gastrointestinal infection at time of enrollment
- Known or suspected toxic megacolon and/or known small bowel ileus
- Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
- History of total colectomy or bariatric surgery
- Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy
- Unable or unwilling to comply with protocol requirements
- Expected life expectancy \< 6 months
- Patients who have CMV \>2,000 copies/mL of whole blood or EBV \>2,000 copies/mL of whole blood.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04059757
Start Date
May 1 2022
End Date
September 1 2023
Last Update
July 7 2022
Active Locations (1)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065