Acute Myeloid Leukemia Clinical Trial
A Study of FMT in Patients With AML Allo HSCT in Recipients
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.
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
Planned continuation of antibacterial antibiotics after the first neutrophil recovery (ANC > 1,000)
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
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There is 1 Location for this study
Minneapolis Minnesota, 55455, United States
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