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

Phase 2

Completed

Conditions: Allogeneic Hematopoietic Cell Transplantation
Acute Myeloid Leukemia

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
AML Patients undergoing Intensive Chemotherapy	Fecal Microbiota Transplant (FMT)	-
AML Patients undergoing Intensive Chemotherapy Control	Placebo	-
Patients undergoing Allo-HCT Patients	Fecal Microbiota Transplant (FMT)	-
Patients undergoing Allo-HCT Patients Control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections	4 Months	Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.

Secondary Outcome Measures

Name	Time	Method
FMT Engraftment	4 Weeks after first FMT treatment	Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
Number of Bacterial Infections	4 Months after first FMT treatment	Number of Bacterial Infections. Monitored each visit through safety assessment.
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)	Day 180 post-HCT, up to 7 months	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.
Number of BSI of Suspected Gut Origin	1 week after first FMT treatment	Number of BSI of suspected gut origin. Monitored each visit through safety assessment.
Number of Fungal Infections	4 Months after first FMT treatment	Number of Fungal Infections. Monitored each visit through safety assessment.
Number of Viral Infections	4 Months after first FMT treatment	Number of Viral Infections. Monitored each visit through safety assessment.