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Trial record 16 of 22 for:    capsule | Recruiting Studies | fecal microbiota transplantation

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

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ClinicalTrials.gov Identifier: NCT03678493
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

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
Acute Myeloid Leukemia Allogeneic Hematopoietic Cell Transplantation Biological: Fecal Microbiota Transplant (FMT) Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 : September 9, 2019
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026


Arm Intervention/treatment
Experimental: AML Patients undergoing Intensive Chemothera Biological: Fecal Microbiota Transplant (FMT)
Oral Capsule
Other Name: 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 Name: FMT

Placebo Comparator: AML Patients undergoing Allo-HCT Patients Control Other: Placebo
Oral Capsule




Primary Outcome Measures :
  1. Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections [ Time Frame: 4 Months ]
    Incidence of infections infections until 4 months after the first intervention


Secondary Outcome Measures :
  1. Rate of FMT Engraftment [ Time Frame: 2 Weeks post-FMT ]
    Rate of FMT Engraftment

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

  3. Incidence of acute grade II-IV GVHD [ Time Frame: Day 180 post-HCT ]
    Allo-HCT cohort: incidence of acute grade II-IV GVHD

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

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

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678493


Contacts
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Contact: Amanda J Kabage, MS 6126242956 kabage@umn.edu

Locations
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United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
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Principal Investigator: Armin Rashidi, MD, PhD University of Minnesota, Division of Hematology, Oncology and Transplantation

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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03678493     History of Changes
Other Study ID Numbers: 2017LS170
MT2018-01 ( Other Identifier: University of Minnesota Masonic Cancer Center )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms