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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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