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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678493
• Other study ID #: 2017LS170
• Secondary ID: MT2018-01
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2019
• Est. completion date: December 4, 2023

Study information

• Verified date: April 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 4, 2023
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Allogeneic Hematopoietic Cell Transplantation
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• Fecal Microbiota Transplant (FMT)
Oral Capsule

Other:
• Placebo
Oral Capsule

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 Months
Secondary	FMT Engraftment	Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.	2 Weeks after first FMT treatment
Secondary	FMT Engraftment	Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.	4 Weeks after first FMT treatment
Secondary	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.	Day 180 post-HCT, up to 7 months
Secondary	Number of BSI of Suspected Gut Origin	Number of BSI of suspected gut origin. Monitored each visit through safety assessment.	1 week after first FMT treatment
Secondary	Number of Bacterial Infections	Number of Bacterial Infections. Monitored each visit through safety assessment.	4 Months after first FMT treatment
Secondary	Number of Viral Infections	Number of Viral Infections. Monitored each visit through safety assessment.	4 Months after first FMT treatment
Secondary	Number of Fungal Infections	Number of Fungal Infections. Monitored each visit through safety assessment.	4 Months after first FMT treatment