Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cell Transplant: A Pilot Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

Qualifiers

Men and women ≥ 18 years of age

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fecal Microbial Transplant Enema
  • Fecal Microbial Transplant Enema

Treatment groups

20 Participants
are divided into 2 treatment groups