A Study of FMT in Patients With AML Allo HSCT in Recipients
A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2023
CompletedResults Posted
Study results publicly available
May 16, 2024
CompletedMay 16, 2024
April 1, 2024
2.4 years
September 18, 2018
November 3, 2023
April 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
FMT Engraftment
2 Weeks after first FMT treatment
FMT Engraftment
4 Weeks 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 Bacterial Infections
4 Months after first FMT treatment
- +2 more secondary outcomes
Study Arms (4)
AML Patients undergoing Intensive Chemotherapy
EXPERIMENTALAML Patients undergoing Intensive Chemotherapy Control
PLACEBO COMPARATORPatients undergoing Allo-HCT Patients
EXPERIMENTALPatients undergoing Allo-HCT Patients Control
PLACEBO COMPARATORInterventions
Oral Capsule
Oral Capsule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Kazadi D, Halaweish H, Khan MH, Hoeschen A, Cao Q, Luo X, Kabage AJ, Lopez S, Holtan SG, Weisdorf DJ, Khoruts A, Staley C. Randomized Double-Blind Phase II Trial of Fecal Microbiota Transplantation Versus Placebo in Allogeneic Hematopoietic Cell Transplantation and AML. J Clin Oncol. 2023 Dec 1;41(34):5306-5319. doi: 10.1200/JCO.22.02366. Epub 2023 May 26.
PMID: 37235836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Armin Rashidi, MD, PhD
- Organization
- University of Minnesota, Masonic Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Armin Rashidi, MD, PhD
University of Minnesota, Division of Hematology, Oncology and Transplantation
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2018
First Posted
September 19, 2018
Study Start
September 9, 2019
Primary Completion
February 11, 2022
Study Completion
December 4, 2023
Last Updated
May 16, 2024
Results First Posted
May 16, 2024
Record last verified: 2024-04