NCT03678493CompletedPhase 2
A Study of FMT in Patients With AML Allo HSCT in Recipients
A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 18 Sept 2018
- Start date
- 9 Sept 2019
- Primary completion date
- 11 Feb 2022
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT03678493
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 9 Sept 2019 to the primary completion date, 11 Feb 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are currently receiving or recently received (within 28 days) other investigational agents.
- Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
Lab values
- Planned continuation of antibacterial antibiotics after the first neutrophil recovery (ANC \> 1,000)
Who the study is looking for
- Age≥ 18 years
- Cohort A: Patients undergoing intensive induction chemotherapy for acute myeloid leukemia (AML; newly diagnosed or relapsed/refractory).
- \* Any intensive regimen with planned \~4 weeks of inpatient stay
- Cohort B: Allo-HCT patients
- \* Any allogeneic transplant regimen with planned GVHD prophylaxis containing generic IV Mycophenolate Mofetil (MMF) and tacrolimus (Tac)
- Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least six months post-FMT/placebo
- Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Masonic Cancer Center at University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.