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

RecruitingPhase 3

A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia

Who can join

Ages 1 to 25 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Children's Oncology Group · Participants: 556 · Started: Aug 14, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07022678

Locations in the U.S.

AlabamaChildren's Hospital of Alabama, Birmingham
ArkansasArkansas Children's Hospital, Little Rock
CaliforniaValley Children's Hospital, Madera
Kaiser Permanente-Oakland, Oakland
ColoradoRocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver
DelawareAlfred I duPont Hospital for Children, Wilmington
FloridaGolisano Children's Hospital of Southwest Florida, Fort Myers
Nemours Children's Clinic-Jacksonville, Jacksonville
Nemours Children's Hospital, Orlando
Nemours Children's Clinic - Pensacola, Pensacola
GeorgiaChildren's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta
IllinoisLurie Children's Hospital-Chicago, Chicago
IowaBlank Children's Hospital, Des Moines
KentuckyUniversity of Kentucky/Markey Cancer Center, Lexington (Not yet recruiting)
Norton Children's Hospital, Louisville
MaineMaine Children's Cancer Program, Scarborough
MichiganC S Mott Children's Hospital, Ann Arbor
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
Bronson Methodist Hospital, Kalamazoo
New MexicoPresbyterian Hospital, Albuquerque
New YorkAlbany Medical Center, Albany
Montefiore Medical Center - Moses Campus, The Bronx
North DakotaSanford Broadway Medical Center, Fargo
OhioRainbow Babies and Childrens Hospital, Cleveland
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo
PennsylvaniaGeisinger Medical Center, Danville
Children's Hospital of Philadelphia, Philadelphia
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
TennesseeEast Tennessee Childrens Hospital, Knoxville
The Children's Hospital at TriStar Centennial, Nashville
TexasDell Children's Medical Center of Central Texas, Austin
Driscoll Children's Hospital, Corpus Christi
Medical City Dallas Hospital, Dallas
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
VirginiaUniversity of Virginia Cancer Center, Charlottesville
Children's Hospital of The King's Daughters, Norfolk
WashingtonProvidence Sacred Heart Medical Center and Children's Hospital, Spokane
WisconsinSaint Vincent Hospital Cancer Center Green Bay, Green Bay
University of Wisconsin Carbone Cancer Center - University Hospital, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.