Actively Recruiting
Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
40
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age on the day of signing informed consent
- Histologically or cytologically confirmed diagnosis of B-cell lymphomas
- Planned to receive FDA approved standard anti-CD19 Axicabtagene Ciloleucel therapy
- Received or currently receiving high-risk broad-spectrum antibiotics for at least two days within 180 days before scheduled Axicabtagene Ciloleucel infusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, evaluated within 7 days before consent
- Provides written informed consent or has a legally acceptable representative
- Absolute neutrophil counts greater than 1000/µL at fecal enema administration
- Adequate liver function: total bilirubin ≤1.5× upper limit of normal (ULN) (≤3× if Gilbert's syndrome), AST and ALT ≤2.5× ULN (≤4× ULN if liver metastases present)
- Adequate kidney function: estimated creatinine clearance >30 mL/min by Cockcroft-Gault formula or 24-hour urine collection
- Use of highly effective contraception for males and females if risk of conception exists, starting 30 days before first study drug and continuing during treatment and specified months after
You will not qualify if you...
- Major surgery within the last 4 weeks without adequate recovery
- Receipt of live vaccine within 30 days prior to first study drug dose
- Diagnosis of primary immunodeficiency (excluding IgA deficiency)
- Any condition or therapy that may confound study results or interfere with full participation
- Known psychiatric or substance abuse disorders interfering with cooperation
- Pregnant or nursing women
- Positive serum pregnancy test within 72 hours prior to enrollment for women of childbearing age
- History of irritable bowel disease or inflammatory bowel disease
- Difficulty with oral administration or risk of aspiration (e.g., neurological issues)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Neeraj Saini, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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