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

Masonic Cancer Center, University of Minnesota1 site in 1 country100 target enrollmentSeptember 9, 2019

ConditionsAcute Myeloid Leukemia Allogeneic Hematopoietic Cell Transplantation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: Masonic Cancer Center, University of Minnesota
Enrollment: 100
Locations: 1
Primary Endpoint: Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 9, 2019

End Date

December 4, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Masonic Cancer Center, University of Minnesota

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

FMT Engraftment(4 Weeks after first FMT treatment)
Number of Bacterial Infections(4 Months after first FMT treatment)
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)(Day 180 post-HCT, up to 7 months)
Number of BSI of Suspected Gut Origin(1 week after first FMT treatment)
Number of Fungal Infections(4 Months after first FMT treatment)
Number of Viral Infections(4 Months after first FMT treatment)