Pilot Study on Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06218602

Provider View

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

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).

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