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

Prior treatment

• Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record.

Other illness

• Patients with Down syndrome-associated AML.
• 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.

Other

• Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.

• 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.