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

Primary Purpose

Acute Myeloid Leukemia, Allogeneic Hematopoietic Cell Transplantation

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fecal Microbiota Transplant (FMT)

Placebo

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, Allo-HCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Masonic Cancer Center at University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

AML Patients undergoing Intensive Chemothera

AML Patients undergoing Intensive Chemotherapy Control

AML Patients undergoing Allo-HCT Patients

AML Patients undergoing Allo-HCT Patients Control

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections

Incidence of infections infections until 4 months after the first intervention

Secondary Outcome Measures

Rate of FMT Engraftment

Incidence of acute grade II-IV GVHD

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

Incidence of BSI of suspected gut origin

Incidence of Bacterial Infections

Incidence of Viral Infections

Incidence of Fungal Infections

Full Information

NCT ID

NCT03678493

First Posted

September 18, 2018

Last Updated

September 8, 2023

Sponsor

Masonic Cancer Center, University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT03678493

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 9, 2019 (Actual)

Primary Completion Date

February 11, 2022 (Actual)

Study Completion Date

January 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Masonic Cancer Center, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Allogeneic Hematopoietic Cell Transplantation

Keywords

AML, Allo-HCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AML Patients undergoing Intensive Chemothera

Arm Type

Experimental

Arm Title

AML Patients undergoing Intensive Chemotherapy Control

Arm Type

Placebo Comparator

Arm Title

AML Patients undergoing Allo-HCT Patients

Arm Type

Experimental

Arm Title

AML Patients undergoing Allo-HCT Patients Control

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Fecal Microbiota Transplant (FMT)

Other Intervention Name(s)

FMT

Intervention Description

Oral Capsule

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Oral Capsule

Primary Outcome Measure Information:

Title

Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections

Description

Incidence of infections infections until 4 months after the first intervention

Time Frame

4 Months

Secondary Outcome Measure Information:

Title

Rate of FMT Engraftment

Description

Rate of FMT Engraftment

Time Frame

2 Weeks post-FMT

Title

Rate of FMT Engraftment

Description

Rate of FMT Engraftment

Time Frame

4 Weeks post-FMT

Title

Incidence of acute grade II-IV GVHD

Description

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

Time Frame

Day 180 post-HCT

Title

Incidence of BSI of suspected gut origin

Description

Incidence of BSI of suspected gut origin

Time Frame

1 week post-FMT

Title

Incidence of Bacterial Infections

Description

Incidence of Bacterial Infections

Time Frame

4 Months post-intervention

Title

Incidence of Viral Infections

Description

Incidence of Viral Infections

Time Frame

4 Months post-intervention

Title

Incidence of Fungal Infections

Description

Incidence of Fungal Infections

Time Frame

4 Months post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Armin Rashidi, MD, PhD

Organizational Affiliation

University of Minnesota, Division of Hematology, Oncology and Transplantation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Masonic Cancer Center at University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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