Fecal Microbiota Transplantation for Cancer
(FMT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores fecal microbiota transplantation (FMT), which transfers healthy bacteria from a donor's stool to a patient, in individuals with certain blood cancers. The goal is to determine if FMT is safe and feasible for patients with B-cell lymphoma undergoing CAR-T therapy or those with acute myeloid leukemia or myelodysplastic syndrome receiving stem cell transplants. The trial divides participants into two groups: one receiving FMT with CAR-T therapy and the other with stem cell transplants. Suitable candidates include those diagnosed with B-cell lymphoma or specific blood disorders, such as AML, who qualify for certain cancer therapies. As an unphased trial, this study allows patients to contribute to groundbreaking research that could lead to new treatment options.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that fecal microbiota transplantation (FMT) is safe for various conditions. For instance, in patients with viral diseases, FMT cleared viruses and improved health without major safety issues. Long-term evidence also supports its safety, with few new medical problems reported after more than a year of follow-up.
Research suggests that when combined with CAR-T therapy, FMT might reduce gut problems in patients with B-cell lymphoma, with most side effects being mild. Similar safety has been observed when FMT was used with donor stem cell transplants, improving gut health without causing significant harm.
Overall, FMT appears to have a good safety record, especially for those with weakened immune systems, such as transplant patients. Most side effects are minor and manageable.12345Why are researchers excited about this trial?
Unlike the standard cancer treatments, which often focus on chemotherapy, radiation, or targeted therapies, fecal microbiota transplantation (FMT) is unique because it involves transferring beneficial bacteria from a healthy donor to the patient's gut. Researchers are excited about FMT because it could enhance the effectiveness of cancer treatments like CAR-T cell and allogenic stem cell transplants by improving the patient's immune response and reducing treatment-related side effects. The potential to modulate the gut microbiome offers a new avenue for tackling cancer, making FMT a promising addition to current oncological therapies.
What evidence suggests that this trial's treatments could be effective for B-cell lymphoma and acute myeloid leukemia?
Research has shown that fecal microbiota transplantation (FMT) could enhance cancer treatments. In this trial, one group of participants will receive FMT alongside CAR-T cell therapy. Studies have found that FMT can improve the effectiveness of immunotherapy, such as CAR-T cell therapy, by reducing gut-related side effects and enhancing outcomes for patients with B-cell lymphoma. Another group in this trial will receive FMT with donor stem cell transplants. For those receiving donor stem cell transplants, FMT might help prevent issues like graft-versus-host disease, where the donor's immune cells attack the patient's body, and aid in restoring healthy gut bacteria. Evidence suggests that FMT can be safe and beneficial in boosting overall success in these cancer treatments.45678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
FMT Treatment
Participants receive fecal microbiota transplantation prior to cellular therapy and 30 days after cellular therapy treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including standard blood tests and sample collections
Long-term Follow-up
Participants are monitored for long-term safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Fecal Microbial Transplant
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients will receive Fecal microbiota transplantation and CAR-T cell infusion
Patients will receive Fecal microbiota transplantation and allogenic cell trnsplant
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Citations
Fecal microbiota transplantation to enhance cancer ...
Despite lack of adequate study designs to assess efficacy, FMT combined with ICI therapy demonstrated positive effects in various cancer types, but particularly ...
1134 - outcomes of fecal microbiota transplantation (fmt) in ...
The majority were phase I studies. Most patients had advanced melanoma (28%), renal cell carci- noma (25%) and non small cell lung cancer (19.5%) ...
3.
cancertherapyadvisor.com
cancertherapyadvisor.com/features/fecal-microbiota-transplantation-immunotherapy/Fecal Microbiota Transplantation and Immunotherapy
Some preliminary data suggest that FMT may be able to prevent or mitigate typical side effects that have plagued the use of immunotherapy, ...
Fecal Microbiota Transplantation for Reducing Gut-Related ...
FMT may be safe, tolerable and/or effective in reducing gut-related side effects and improving treatment outcomes in patients with B-cell lymphoma receiving CAR ...
Microbiota boost immunotherapy? A meta-analysis dives into ...
Fecal microbiota transplantation (FMT), which alters the gut microbiome, has shown promise in enhancing ICIs' therapeutic effects. Methods. We ...
Safety and efficacy of fecal microbiota transplantation for viral ...
Our findings revealed FMT as a promising, safe treatment for some viral diseases. It improved viral clearance, clinical outcomes, and inflammation.
Long-Term Safety Outcomes of Fecal Microbiota ...
At long-term follow-up beyond 12 months, 16 patients reported 21 new-onset medical conditions confirmed by electronic medical records. All were ...
Fecal Microbiota Transplantation in Patients Undergoing ...
To evaluate the safety of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation. We ...
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