Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.
M.D. Anderson Cancer Center
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.
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 me…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 18 years of age on the day of signing informed consent. 2. Histologically/cytologically confirmed diagnosis of B-cell lymphomas. 3. Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel. 4. Participants must have received or is receiving high-risk broad-spectrum antibiotics for minimum of two days within 180 days of scheduled Axicabtagene ciloleucel infusion. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidim…
Interventions
- DrugFecal Microbiota Transplantation
Given by PO
- ProcedureChemotherapy
Given by Infusion
- ProcedureCAR-T Therapy
Given by Infusion
Location
- MD Anderson Cancer CenterHouston, Texas