Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cell Transplant: A Pilot Study
Canada20 participantsStarted 2026-04-15
Plain-language summary
This is a single site pilot trial will evaluate the feasibility and safety of fecal microbiota transplantation (FMT) in patients with B-cell lymphoma who are undergoing CAR-T or in patients with moderate to high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing allogeneic stem cell transplantation.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men and women ≥ 18 years of age
✓. Diagnosis of the following:
✓. Indolent or aggressive B-cell lymphoma eligible for standard or care CAR-T therapy (Cohort A), or
✓. Patients with AML or high risk MDS with indication to undergo reduced-intensity conditioning alloSCT, with an available matched related, unrelated, or haploidentical donor (Cohort B)
✓. ECOG 0-1
✓. Adequate marrow function defined by:
✓. Hemoglobin \>80 g/L without transfusion dependence within the last 7 days
✓. Platelet count \>20 x 109/L without transfusion dependence within the last 7 days
Exclusion criteria
✕. For patients undergoing alloSCT (Cohort B): plan to undergo myeloablative conditioning
✕. Use of investigational agents within the last 4 weeks before enrollment.
✕. Active or uncontrolled infection
✕. Autoimmune disorder currently being treated with disease-modifying therapy or with \>10mg/day prednisone