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New treatment option for Lymphoma Receiving CAR-T Therapy
Official title Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cell Transplant: A Pilot Study
ClinicalTrials.gov ID: NCT07509450
What this study is testing
What is Fecal Microbial Transplant Enema?
Fecal Microbial Transplant Enema is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma receiving car-t therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- ECOG 0-1
You likely can't join if
- 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
- Inflammatory bowel disease
- History of intestinal perforation
See the full eligibility 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
- Neutrophil count \>1.0 x 109/L without growth factor support within the last 7 days
- Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 1.5 x ULN (unless...
- Adequate renal function as defined as creatinine clearance ≥ 30 mL/min directly measured with a 24-hour urine collection or calculated according to the modified formula of Cockcroft-Gault equation or Chronic Kidney...
- Life expectancy \>6 months
- Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of protocol therapy. Men who are sexually active...
- Willing and able to participate in all required evaluations and procedures in this study.
- Ability to understand and the willingness to sign a written informed consent.
- 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
- Inflammatory bowel disease
- History of intestinal perforation
- Gastrointestinal surgical procedure within the past 4 weeks before enrollment
- Pregnant or breast-feeding patients
- HIV infection with detectable viral load or CD4 count \<200
- Serologic status reflecting active hepatitis B or C infection as follows:
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA. (Note, patients with undetectable HBV DNA are permitted to enroll if they are on...
- Patients with presence of hepatitis C virus (HCV) antibody and HCV RNA detectable
- History of infection or known colonization with antibiotic resistant organism in the last two years before enrollment (including ESBL, MRSA, VISA, VRSA, VRE, CPE)
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.