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

Launched by FRED HUTCHINSON CANCER CENTER · Aug 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether a treatment called fecal microbiota transplantation can help prevent a serious condition known as acute graft versus host disease (GVHD) in adults who are receiving a type of cancer treatment called allogeneic hematopoietic cell transplantation (HCT). In this trial, participants will receive processed fecal material orally to help restore a healthy balance of bacteria in their gut, which can be disrupted during treatment. The goal is to see if this can reduce the chances of developing severe GVHD, which occurs when the donor's immune cells attack the recipient's body.

To be eligible for this trial, participants need to be at least 18 years old, able to take oral medications, and scheduled for an allogeneic HCT with specific donor types. They should not have any severe food allergies or be currently pregnant or breastfeeding. If enrolled, participants can expect to receive either the fecal microbiota treatment or a placebo (a non-active treatment) while being closely monitored for their health. This trial is currently recruiting participants and aims to provide important insights into how gut health may play a role in preventing complications after HCT.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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