NCT07022678 Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
| NCT ID | NCT07022678 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Children's Oncology Group |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 556 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2032-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 556 participants in total. It began in 2026-05-26 with a primary completion date of 2032-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Jennifer J Wilkes
PRINCIPAL INVESTIGATOR
Children's Oncology Group
Frequently Asked Questions
Who can join the NCT07022678 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 25 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07022678 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 556 participants.
Is NCT07022678 currently recruiting?
Yes, NCT07022678 is actively recruiting participants. Visit ClinicalTrials.gov or contact Children's Oncology Group to inquire about joining.
Where is the NCT07022678 trial being conducted?
This trial is being conducted at Little Rock, United States, Madera, United States, Oakland, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT07022678 clinical trial?
NCT07022678 is sponsored by Children's Oncology Group. The principal investigator is Jennifer J Wilkes at Children's Oncology Group. The trial plans to enroll 556 participants.
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