OncoMatch/Clinical Trials/NCT06218602
Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.
Is NCT06218602 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fecal Microbiota Transplantation for lymphoma.
Treatment: Fecal Microbiota Transplantation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: high-risk broad-spectrum antibiotics (carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime), anaerobic antibiotics (metronidazole, clindamycin, amoxicillin-sulbactam)) — within 180 days of scheduled Axicabtagene ciloleucel infusion
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, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam.
Lab requirements
Blood counts
absolute neutrophil count > 1000/ul at time of administration of fecal enema
Kidney function
estimated creatinine clearance >30 mL/min (Cockcroft-Gault or 24-hour urine collection)
Liver function
total bilirubin ≤ 1.5 x ULN (≤ 3x ULN if Gilbert's syndrome); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; if liver metastases present, AST and ALT ≤ 4 x ULN
Absolute neutrophil counts should be greater than 1000/ul at the time of administration of fecal enema. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 ≤ x the upper limit of normal (ULN)[except if Gilberts syndrome and then total bilirubin ≤ 3x is allowed], an AST, level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT levels must be ≤ 4 x ULN. Adequate renal function defined by an estimated creatinine clearance >30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify