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Microbiota Restoration
Fecal Microbiota Transplant for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Armin Rashidi, MD, PhD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort A: Patients undergoing intensive induction chemotherapy for acute myeloid leukemia (AML; newly diagnosed or relapsed/refractory) with any intensive regimen with planned ~4 weeks of inpatient stay
Cohort B: Allo-HCT patients with any allogeneic transplant regimen with planned GVHD prophylaxis containing generic IV Mycophenolate Mofetil (MMF) and tacrolimus (Tac)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will study whether Fecal Microbiota Transplant (FMT) is effective in treating patients with leukemia who are undergoing intensive chemotherapy or Allo-HCT. Patients will be given FMT or a placebo, and the efficacy of the treatment will be measured.
Who is the study for?
Adults with acute myeloid leukemia (AML) undergoing chemotherapy or allogeneic hematopoietic stem cell transplantation (Allo-HCT) can join. They must consent to the study and agree to use birth control for six months post-treatment. Excluded are those on continuous antibiotics post-neutrophil recovery, recent investigational drug users, or pregnant/breastfeeding women.Check my eligibility
What is being tested?
The trial is testing Fecal Microbiota Transplant (FMT) versus a placebo in AML patients receiving chemotherapy and Allo-HCT recipients. Participants will be randomly assigned in a 2:1 ratio to receive up to three treatments of either FMT or placebo after antibiotic exposure.See study design
What are the potential side effects?
While specific side effects of FMT are not listed here, they may include digestive discomfort, bloating, cramping, nausea, fever, and potential infection risks due to changes in gut bacteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am starting strong chemotherapy for AML and will be in the hospital for about 4 weeks.
Select...
I am in a group receiving a specific transplant with MMF and Tac for GVHD prevention.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections
Secondary outcome measures
Incidence of BSI of suspected gut origin
Incidence of Bacterial Infections
Incidence of Fungal Infections
+3 moreSide effects data
From 2019 Phase 1 & 2 trial • 15 Patients • NCT0233065317%
Non-Cardiac Chest Pain
17%
Abnormal Lab Values
17%
Grade 3 Colitis
17%
Eczema/Rash
8%
Sore Throat
8%
Upper Respiratory Infection
8%
Fever
8%
Epiploic Appendagitis
8%
Grade 3 Sinus Tachycardia
8%
Eye Disorder/Blurred Vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fecal Microbiota Transplant (FMT)
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: AML Patients undergoing Intensive ChemotheraExperimental Treatment1 Intervention
Group II: AML Patients undergoing Allo-HCT PatientsExperimental Treatment1 Intervention
Group III: AML Patients undergoing Intensive Chemotherapy ControlPlacebo Group1 Intervention
Group IV: AML Patients undergoing Allo-HCT Patients ControlPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant (FMT)
2015
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,506 Total Patients Enrolled
Armin Rashidi, MD, PhDPrincipal InvestigatorUniversity of Minnesota, Division of Hematology, Oncology and Transplantation
6 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA condone Fecal Microbiota Transplantation?
"Fecal Microbiota Transplant (FMT) is a Phase 2 clinical trial, which suggests that while there is some evidence for its safety, none for efficacy."
Answered by AI
Are patients currently being sought for this experiment?
"No, this trial is not currently recruiting patients according to the latest information available on clinicaltrials.gov. This study was initially posted on September 9th, 2019 and last updated November 2nd, 2022. There are however 1601 other trials that are actively seeking participants."
Answered by AI
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