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

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Allogeneic Hematopoietic Cell Transplantation; Acute Myeloid Leukemia

Treatments: Biological: Fecal Microbiota Transplant (FMT); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03678493

2017LS170

MT2018-01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups, including a placebo group

AML Patients undergoing Intensive Chemotherapy

Experimental group

Treatment:

Biological: Fecal Microbiota Transplant (FMT)

AML Patients undergoing Intensive Chemotherapy Control

Placebo Comparator group

Treatment:

Other: Placebo

Patients undergoing Allo-HCT Patients

Experimental group

Treatment:

Biological: Fecal Microbiota Transplant (FMT)

Patients undergoing Allo-HCT Patients Control

Placebo Comparator group

Treatment:

Other: Placebo