Pilot Study on Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06218602
This clinical trial is exploring whether adding fecal microbiota transplantation (FMT) can help manage gut-related side effects in lymphoma patients undergoing standard CAR-T cell therapy with Axicabtagene Ciloleucel.
Patient Parameters
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Program Overview
The aim of this study is to determine if fecal microbiota transplantation (FMT) can effectively treat gut-related side effects caused by antibiotics in patients receiving Axicabtagene Ciloleucel, a standard CAR-T cell therapy for lymphoma. Researchers will compare the safety and effectiveness of this combination treatment with the standard therapy alone.
Description
The study has several goals:
Primary Goals:
- To evaluate the safety of combining FMT with Axicabtagene Ciloleucel therapy and compare it to the standard CAR-T cell therapy.
- To assess how well patients respond to the combination of FMT and Axicabtagene Ciloleucel therapy after 30 days, compared to the standard treatment.
Secondary Goals:
- To evaluate progression-free survival (PFS) and overall survival (OS) in patients with and without FMT.
- To observe changes in the gut microbiome of lymphoma patients after receiving FMT.
- To study changes in blood and stool substances after FMT.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of B-cell lymphoma.
- Scheduled to receive FDA-approved Axicabtagene Ciloleucel therapy.
- Have taken or are taking high-risk antibiotics for at least two days within 180 days before the scheduled Axicabtagene Ciloleucel infusion.
- Have an ECOG performance status of 0 to 2, assessed within 7 days before signing consent.
- Provide written informed consent.
- Have an absolute neutrophil count greater than 1000/ul at the time of FMT.
- Have adequate liver function, with specific limits on bilirubin, AST, and ALT levels.
- Have adequate kidney function, with creatinine clearance over 30 mL/min.
- Use highly effective contraception if there is a risk of conception, starting 30 days before the study, during the study, and for 12 months after for females and 4 months after for males.
Exclusion Criteria
- Recent major surgery within the last 4 weeks without full recovery.
- Received a live vaccine within 30 days before the first study drug dose.
- Have a primary immunodeficiency (except IgA deficiency).
- Have any condition or treatment that might interfere with the study results or participation.
- Have known psychiatric or substance abuse issues that would affect cooperation.
- Pregnant or nursing women.
- Positive pregnancy test for women of childbearing age within 72 hours before enrollment.
- History of irritable bowel disease or inflammatory bowel disease.
- Difficulty with oral administration or risk of aspiration (e.g., due to neurological issues).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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