Acute Myeloid Leukemia Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT03678493

Recruitment Status:

Completed

Sponsor:

Masonic Cancer Center, University of Minnesota

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There is 1 Location for this study

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Masonic Cancer Center at University of Minnesota
Minneapolis Minnesota, 55455, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT03678493

Recruitment Status:

Completed

Sponsor:


Masonic Cancer Center, University of Minnesota

How clear is this clinincal trial information?

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