Clinical trial NCT03678493: A Study of FMT in Patients With AML Allo HSCT in Recipients
Official title: A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Allogeneic Hematopoietic Cell Transplantation
Keywords: AML
Allo-HCT
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections
timeFrame: 4 Months
Secondary outcomes:
measure: FMT Engraftment
timeFrame: 2 Weeks after first FMT treatment
measure: FMT Engraftment
timeFrame: 4 Weeks after first FMT treatment
measure: Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
timeFrame: Day 180 post-HCT, up to 7 months
measure: Number of BSI of Suspected Gut Origin
timeFrame: 1 week after first FMT treatment
measure: Number of Bacterial Infections
timeFrame: 4 Months after first FMT treatment
measure: Number of Viral Infections
timeFrame: 4 Months after first FMT treatment
measure: Number of Fungal Infections
timeFrame: 4 Months after first FMT treatment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota, Division of Hematology, Oncology and Transplantation
name: Armin Rashidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: