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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Myeloid Leukemia, Allogeneic Hematopoietic Cell Transplantation

Intervention / Treatment
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* Biological: Fecal Microbiota Transplant (FMT)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AML Patients undergoing Intensive Chemothera<br> | Biological: Fecal Microbiota Transplant (FMT)<br>* Oral Capsule<br>* Other names: FMT;|
| Placebo Comparator: AML Patients undergoing Intensive Chemotherapy Control<br> | Other: Placebo<br>* Oral Capsule<br>|
| Experimental: AML Patients undergoing Allo-HCT Patients<br> | Biological: Fecal Microbiota Transplant (FMT)<br>* Oral Capsule<br>* Other names: FMT;|
| Placebo Comparator: AML Patients undergoing Allo-HCT Patients Control<br> | Other: Placebo<br>* Oral Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections | Incidence of infections infections until 4 months after the first intervention | 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of FMT Engraftment | Rate of FMT Engraftment | 2 Weeks post-FMT | 
| Rate of FMT Engraftment | Rate of FMT Engraftment | 4 Weeks post-FMT | 
| Incidence of acute grade II-IV GVHD | Allo-HCT cohort: incidence of acute grade II-IV GVHD | Day 180 post-HCT | 
| Incidence of BSI of suspected gut origin | Incidence of BSI of suspected gut origin | 1 week post-FMT | 
| Incidence of Bacterial Infections | Incidence of Bacterial Infections | 4 Months post-intervention | 
| Incidence of Viral Infections | Incidence of Viral Infections | 4 Months post-intervention | 
| Incidence of Fungal Infections | Incidence of Fungal Infections | 4 Months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Allo-HCT