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RECRUITING Phase 3 ClinicalTrials.gov

Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia

Sponsor: Children's Oncology Group • ClinicalTrials.gov ID: NCT07022678

Registry updated: 2026-09-04
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Description

This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.

Interventions

  • Best Practice (Other)
    Given standard chemotherapy
  • Biospecimen Collection (Procedure)
    Undergo saliva sample collection
  • Cytarabine (Drug)
    Given IV
  • Electronic Health Record Review (Other)
    Ancillary studies
  • Placebo Administration (Drug)
    Given intraorally
  • Xylitol-containing Oral Wipe (Other)
    Given intraorally

Eligibility criteria

Inclusion Criteria: * Patient must be ≥ 1 year to ≤ 25 years old at enrollment. * Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria. * Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must: * Contain IV cytarabine (liposomal formulations allowed), and * The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles. Note: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted. * Minimum of one visible or erupted tooth. * Agree to avoid xylitol containing gum or toothpaste during intervention period. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Exclusion Criteria: * Patients with Down syndrome-associated AML. * Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record. * Patients with known history of allergy to xylitol. * Patients with known history of allergy to grapes or grape flavoring. * Patients who are actively being treated for an oral organism related blood stream infection. * Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.

Conditions

Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia

Locations

  • Children's Hospital of Alabama — Birmingham, Alabama, United States
  • Arkansas Children's Hospital — Little Rock, Arkansas, United States
  • Valley Children's Hospital — Madera, California, United States
  • Kaiser Permanente-Oakland — Oakland, California, United States
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
  • Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
  • Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
  • Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
  • Nemours Children's Hospital — Orlando, Florida, United States
  • Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
  • Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
  • Blank Children's Hospital — Des Moines, Iowa, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • Norton Children's Hospital — Louisville, Kentucky, United States
  • Maine Children's Cancer Program — Scarborough, Maine, United States
  • C S Mott Children's Hospital — Ann Arbor, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
  • Bronson Methodist Hospital — Kalamazoo, Michigan, United States
  • Presbyterian Hospital — Albuquerque, New Mexico, United States
  • Albany Medical Center — Albany, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital — Toledo, Ohio, United States
  • Geisinger Medical Center — Danville, Pennsylvania, United States
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
  • Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
  • East Tennessee Childrens Hospital — Knoxville, Tennessee, United States
  • The Children's Hospital at TriStar Centennial — Nashville, Tennessee, United States
  • Dell Children's Medical Center of Central Texas — Austin, Texas, United States
  • Driscoll Children's Hospital — Corpus Christi, Texas, United States
  • Medical City Dallas Hospital — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
  • Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
  • Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
  • University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record