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

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University of Minnesota (UMN)

Status and phase

Active, not recruiting
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

119 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)

119 participants in 4 patient groups, including a placebo group

AML Patients undergoing Intensive Chemothera
Experimental group
Treatment:
Biological: Fecal Microbiota Transplant (FMT)
AML Patients undergoing Intensive Chemotherapy Control
Placebo Comparator group
Treatment:
Other: Placebo
AML Patients undergoing Allo-HCT Patients
Experimental group
Treatment:
Biological: Fecal Microbiota Transplant (FMT)
AML Patients undergoing Allo-HCT Patients Control
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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