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Completed

NCT Number: NCT03678493

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.

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Key information

Conditions

Acute Myeloid Leukemia Allogeneic Hematopoietic Cell Transplantation Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbiota Transplant (FMT)

Biological

Oral Capsule

Other names: FMT

Placebo

Other

Oral Capsule

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. Number of Bacterial Infections

    Time frame: 4 Months after first FMT treatment

    Number of Bacterial Infections. Monitored each visit through safety assessment.

  6. Number of Viral Infections

    Time frame: 4 Months after first FMT treatment

    Number of Viral Infections. Monitored each visit through safety assessment.

  7. Number of Fungal Infections

    Time frame: 4 Months after first FMT treatment

    Number of Fungal Infections. Monitored each visit through safety assessment.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 19, 2018
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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