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

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03678493
Collaborator
(none)
119
Enrollment
1
Location
4
Arms
85.7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Fecal Microbiota Transplant (FMT)
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
Actual Study Start Date :
Sep 9, 2019
Anticipated Primary Completion Date :
Sep 22, 2022
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections [4 Months]

      Incidence of infections infections until 4 months after the first intervention

    Secondary Outcome Measures

    1. Rate of FMT Engraftment [2 Weeks post-FMT]

      Rate of FMT Engraftment

    2. Rate of FMT Engraftment [4 Weeks post-FMT]

      Rate of FMT Engraftment

    3. Incidence of acute grade II-IV GVHD [Day 180 post-HCT]

      Allo-HCT cohort: incidence of acute grade II-IV GVHD

    4. Incidence of BSI of suspected gut origin [1 week post-FMT]

      Incidence of BSI of suspected gut origin

    5. Incidence of Bacterial Infections [4 Months post-intervention]

      Incidence of Bacterial Infections

    6. Incidence of Viral Infections [4 Months post-intervention]

      Incidence of Viral Infections

    7. Incidence of Fungal Infections [4 Months post-intervention]

      Incidence of Fungal Infections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ageā‰„ 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Masonic Cancer Center at University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Principal Investigator: Armin Rashidi, MD, PhD, University of Minnesota, Division of Hematology, Oncology and Transplantation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT03678493
    Other Study ID Numbers:
    • 2017LS170
    • MT2018-01
    First Posted:
    Sep 19, 2018
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    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
    Keywords provided by Masonic Cancer Center, University of Minnesota
    AML
    Allo-HCT
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Feb 18, 2022