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

Lymphoma Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Primary Objectives

1. To assess the toxicity of combination of FMT with anti-CD19 Axicabtagene ciloleucel therapy and compare it with standard of care Arm B with anti-CD19 CAR-T arm

2. To assess the response in participants treated with the combination of FMT and Axicabtagene ciloleucel CAR T-cell therapy at day 30 and compare it with standard of care Arm B with anti-CD19 CAR-T arm.

Secondary Objectives

1. To assess PFS and OS among participants with and without FMT.

2. To assess changes in gut microbiome of lymphoma participants after FMT.

3. To assess dynamic changes in serum and stool metabolites after FMT. ;

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT06218602
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Neeraj Saini, MD
• Phone: (713) 792-4504
• Email: nsaini@mdanderson.org
• Status: Recruiting
• Phase: Phase 2
• Start date: February 19, 2024
• Completion date: September 10, 2026