Status:
RECRUITING
Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Acute Graft Versus Host Disease
Hematopoietic and Lymphatic System Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allog...
Detailed Description
OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups. GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days ...
Eligibility Criteria
Inclusion
- Age \>= 18
- Signed informed consent
- Able to take oral medications
- Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed
- Planned GVHD prophylaxis using one of the following regimens:
- Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate
- Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil (MMF)
- Sirolimus plus cyclosporine plus MMF
- Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF or sirolimus)
- One of the following HCT donor types:
- Human leukocyte antigen (HLA)-matched sibling donor
- 9/10 or 10/10 HLA-matched unrelated donor
- HLA- haploidentical donor
- Cord blood
- Willing to use at least 1 accepted method of contraception until day 180 after transplant and agree to not donate eggs/sperm for 180 days after
- Not pregnant or breast feeding
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Absolute neutrophil count (ANC) recovery to \> 0.5 x 10\^9/L from nadir, without ongoing growth factor support
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Discontinuation of all antibacterial antibiotics (except those used for Pneumocystis jiroveci prophylaxis) for 2 days
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all acute toxicities (other than anemia and thrombocytopenia) to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or lower
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade II-IV acute GVHD
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: No moderate to severe chronic GVHD
- ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibiotics to treat infections. Prophylactic antiviral and antifungal antibiotics used to prevent infections are allowed
Exclusion
- Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization
- History of chronic aspiration or conditions predisposing to aspiration (e.g. neuromuscular disorders)
- Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD. The use of other experimental agents is prohibited unless approved by the principal investigator (PI) of the other trial
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06026371
Start Date
December 12 2023
End Date
March 31 2027
Last Update
September 17 2025
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109