A Study of FMT in Patients With AML Allo HSCT in Recipients

April 22, 2024 updated by: Masonic Cancer Center, University of Minnesota

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: AML Patients undergoing Intensive Chemotherapy Control
Other: Placebo
Oral Capsule
Experimental: AML Patients undergoing Intensive Chemotherapy
Biological: Fecal Microbiota Transplant (FMT)
Oral Capsule
Other Names:
  • FMT
Experimental: Patients undergoing Allo-HCT Patients
Biological: Fecal Microbiota Transplant (FMT)
Oral Capsule
Other Names:
  • FMT
Placebo Comparator: 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 - Number of Infections
Time Frame: 4 Months
Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.
4 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FMT Engraftment
Time Frame: 2 Weeks after first FMT treatment
Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
2 Weeks after first FMT treatment
FMT Engraftment
Time Frame: 4 Weeks after first FMT treatment
Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
4 Weeks after first FMT treatment
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
Time Frame: Day 180 post-HCT, up to 7 months
Percentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV). Monitored each visit through safety assessment. Grade II better, Grade IV worse.
Day 180 post-HCT, up to 7 months
Number of BSI of Suspected Gut Origin
Time Frame: 1 week after first FMT treatment
Number of BSI of suspected gut origin. Monitored each visit through safety assessment.
1 week after first FMT treatment
Number of Bacterial Infections
Time Frame: 4 Months after first FMT treatment
Number of Bacterial Infections. Monitored each visit through safety assessment.
4 Months after first FMT treatment
Number of Viral Infections
Time Frame: 4 Months after first FMT treatment
Number of Viral Infections. Monitored each visit through safety assessment.
4 Months after first FMT treatment
Number of Fungal Infections
Time Frame: 4 Months after first FMT treatment
Number of Fungal Infections. Monitored each visit through safety assessment.
4 Months after first FMT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2019

Primary Completion (Actual)

February 11, 2022

Study Completion (Actual)

December 4, 2023

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)

May 16, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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