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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myeloid Leukemia; Allogeneic Hematopoietic Cell Transplantation
• Intervention / Treatment: Biological: Fecal Microbiota Transplant (FMT); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center at University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AML Patients undergoing Intensive Chemothera	Biological: Fecal Microbiota Transplant (FMT); Oral Capsule; Other Names: FMT
Placebo Comparator: AML Patients undergoing Intensive Chemotherapy Control	Other: Placebo; Oral Capsule
Experimental: AML Patients undergoing Allo-HCT Patients	Biological: Fecal Microbiota Transplant (FMT); Oral Capsule; Other Names: FMT
Placebo Comparator: AML Patients undergoing Allo-HCT Patients Control	Other: Placebo; Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections	Incidence of infections infections until 4 months after the first intervention	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of FMT Engraftment	Rate of FMT Engraftment	2 Weeks post-FMT
Rate of FMT Engraftment	Rate of FMT Engraftment	4 Weeks post-FMT
Incidence of acute grade II-IV GVHD	Allo-HCT cohort: incidence of acute grade II-IV GVHD	Day 180 post-HCT
Incidence of BSI of suspected gut origin	Incidence of BSI of suspected gut origin	1 week post-FMT
Incidence of Bacterial Infections	Incidence of Bacterial Infections	4 Months post-intervention
Incidence of Viral Infections	Incidence of Viral Infections	4 Months post-intervention
Incidence of Fungal Infections	Incidence of Fungal Infections	4 Months post-intervention

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Armin Rashidi, MD, PhD, University of Minnesota, Division of Hematology, Oncology and Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): February 11, 2022
• Study Completion (Estimated): January 4, 2025

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: AML; Allo-HCT
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 2017LS170; MT2018-01 (Other Identifier: University of Minnesota Masonic Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No