Fecal Microbiota Transplantation for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if fecal microbiota transplantation (FMT) can benefit patients with certain types of lymphoma that have returned or are not responding to treatment. The approach uses healthy gut bacteria from donors to restore the gut microbiome, which strong antibiotics and chemotherapy in CAR T-cell therapy can damage. Participants will receive either FMT or a placebo alongside their standard treatment to assess any improvement in their response. This trial may suit individuals with relapsed or treatment-resistant lymphoma who have recently taken high-risk antibiotics and are scheduled for CAR T-cell therapy. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that fecal microbiota transplantation (FMT) is generally safe for patients. FMT uses healthy donor stool to improve gut health and has been successfully applied in cancer treatments. It appears to be a safe and practical option to support cancer therapy, even for those who have undergone intense treatments like chemotherapy and CAR T-cell therapy.
Reports indicate that FMT may help manage treatment-related side effects, especially in the gut, without causing serious issues. Most patients tolerate it well, and FMT could enhance treatment outcomes, particularly for those with difficult-to-treat lymphoma. While no treatment is without risk, FMT seems to be a promising and safe method to support gut health during cancer treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about fecal microbiota transplantation (FMT) for lymphoma because it introduces a novel approach by utilizing gut bacteria to potentially enhance the immune system's response to treatment. Unlike traditional lymphoma treatments that primarily involve chemotherapy or CAR T-cell therapy, FMT aims to restore and balance the gut microbiome, which could improve overall treatment outcomes and reduce side effects. This approach is innovative because it leverages the body's natural bacteria to support and possibly boost the effectiveness of existing therapies like axicabtagene ciloleucel, offering a promising complement to the current standard of care.
What evidence suggests that fecal microbiota transplantation might be an effective treatment for lymphoma?
Studies have shown that fecal microbiota transplantation (FMT) can improve cancer treatment outcomes by restoring a healthy balance of gut bacteria. In this trial, some participants will receive FMT alongside standard care, including CAR T-cell therapy. Research suggests that FMT may also reduce side effects for patients undergoing treatments like CAR T-cell therapy. A review of several studies found that taking fecal microbiota in capsule form was particularly effective, with a success rate of 49%. Early findings indicate that FMT replenishes the gut with beneficial bacteria, supporting the immune system and enhancing treatment effectiveness. By restoring the gut microbiome, FMT aims to improve the body's response to cancer treatment for patients with relapsed or hard-to-treat lymphoma.23456
Who Is on the Research Team?
Karamjeet S Sandhu
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with certain types of lymphoma that have either returned after treatment or haven't responded to treatment, and who have been exposed to strong antibiotics. They must be receiving CAR T-cell therapy, which involves modifying their immune cells to fight cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FMT or placebo orally on specified days before leukapheresis and CAR T cell infusion, with additional doses around neutrophil recovery
Follow-up
Participants are monitored for safety, microbiome diversity, and response rates at multiple timepoints post CAR T cell therapy
Long-term monitoring
Participants are monitored for adverse events and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Axicabtagene Ciloleucel
- Fecal Microbiota Transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator