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

Masonic Cancer Center, University of Minnesota100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Acute Myeloid Leukemia Allogeneic Hematopoietic Cell Transplantation

Interventions

Fecal Microbiota Transplant (FMT)BIOLOGICAL

Oral Capsule

PlaceboOTHER

Oral Capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections

Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.

Time frame: 4 Months

Secondary Outcomes

FMT Engraftment

Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.

Time frame: 2 Weeks after first FMT treatment

FMT Engraftment

Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.

Time frame: 4 Weeks after first FMT treatment

Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)

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.

Time frame: Day 180 post-HCT, up to 7 months

Number of BSI of Suspected Gut Origin

Number of BSI of suspected gut origin. Monitored each visit through safety assessment.

Time frame: 1 week after first FMT treatment

Number of Bacterial Infections

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

Time frame: 4 Months after first FMT treatment

Number of Viral Infections

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

Data from ClinicalTrials.gov

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