RecruitingPhase 2NCT06218602

Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To find out if adding treatment with fecal microbiota transplantation (FMT) is effective at treating gut-related side effects of antibiotic treatment in participants who are receiving standard therapy with anti-CD19 chimeric antigen receptor T-cell (CAR-T cell) therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a fecal microbiota transplant (FMT) — transferring healthy gut bacteria from a donor — can restore a patient's gut microbiome after antibiotic treatment and improve outcomes for lymphoma patients receiving a specific CAR-T cell therapy called axicabtagene ciloleucel (axi-cel). Disruption of gut bacteria by antibiotics may reduce CAR-T effectiveness. **You may be eligible if...** - You are 18 or older with a confirmed B-cell lymphoma - You are scheduled to receive the axi-cel CAR-T therapy as standard care - You have received broad-spectrum antibiotics for at least 2 days in the past 6 months before your CAR-T infusion - Your blood counts and organ function meet study minimums **You may NOT be eligible if...** - You have severe immune system suppression or active graft-versus-host disease - You have active, uncontrolled infection - You received a live vaccine within the past 30 days - You received a stem cell transplant recently (within 3–6 months) - You have serious bowel disease that would make an FMT unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFecal Microbiota Transplantation

Given by PO

PROCEDUREChemotherapy

Given by Infusion

PROCEDURECAR-T Therapy

Given by Infusion


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06218602


Related Trials