ACTIVE_NOT_RECRUITING

Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

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Conditions

Acute Graft Versus Host DiseaseHematopoietic and Lymphatic System Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.

Official Title

Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

Quick Facts

Study Start:2023-12-12
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06026371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18
  2. * Signed informed consent
  3. * Able to take oral medications
  4. * Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed
  5. * Planned GVHD prophylaxis using one of the following regimens:
  6. * Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate
  7. * Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil (MMF)
  8. * Sirolimus plus cyclosporine plus MMF
  9. * Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF or sirolimus)
  10. * One of the following HCT donor types:
  11. * Human leukocyte antigen (HLA)-matched sibling donor
  12. * 9/10 or 10/10 HLA-matched unrelated donor
  13. * HLA- haploidentical donor
  14. * Cord blood
  15. * 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
  16. * Not pregnant or breast feeding
  17. * ELIGIBILITY CRITERIA FOR RANDOMIZATION: Absolute neutrophil count (ANC) recovery to \> 0.5 x 10\^9/L from nadir, without ongoing growth factor support
  18. * ELIGIBILITY CRITERIA FOR RANDOMIZATION: Discontinuation of all antibacterial antibiotics (except those used for Pneumocystis jiroveci prophylaxis) for 2 days
  19. * 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
  20. * ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules
  21. * ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade II-IV acute GVHD
  22. * ELIGIBILITY CRITERIA FOR RANDOMIZATION: No moderate to severe chronic GVHD
  23. * ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibiotics to treat infections. Prophylactic antiviral and antifungal antibiotics used to prevent infections are allowed
  1. * Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization
  2. * History of chronic aspiration or conditions predisposing to aspiration (e.g. neuromuscular disorders)
  3. * 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

Contacts and Locations

Principal Investigator

Armin Rashidi
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

  • Armin Rashidi, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-12-12
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Graft Versus Host Disease
  • Hematopoietic and Lymphatic System Neoplasm