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

NCT07022678 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: ACCL2531NCI-2025-03832COG-ACCL2531U24CA196173UG1CA189955
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Recurrent Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of bloodstream infections (BSI) from oral flora

  Will report the estimated oral organism BSI incidence rates by arm as number of events per 1000 patient-days. Will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of oral organism BSI for the treatment relative to control arm and the corresponding 95% confidence interval.

  Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study

Secondary Outcomes (1)

• Number of BSI from any organism

  Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study

Other Outcomes (4)

• Severe infection (Common Terminology Criteria for Adverse Events [CTCAE] grade 4 or higher sepsis)

  Up to 90 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study

• Neutropenic fever episodes

  Up to 90 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study

• Severe mucositis (CTCAE grade 3 or higher)

  Up to 90 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study

Study Arms (2)

Arm I (xylitol dental wipe)

EXPERIMENTAL

Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC \>= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.

Other: Best Practice; Procedure: Biospecimen Collection; Drug: Cytarabine; Other: Electronic Health Record Review; Other: Xylitol-containing Oral Wipe

Arm II (non-xylitol dental wipe)

ACTIVE COMPARATOR

Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC \>= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.

Other: Best Practice; Procedure: Biospecimen Collection; Drug: Cytarabine; Other: Electronic Health Record Review; Drug: Placebo Administration

Interventions

Best Practice OTHER

Given standard chemotherapy

Also known as: standard of care, standard therapy

Arm I (xylitol dental wipe); Arm II (non-xylitol dental wipe)

Cytarabine DRUG

Given IV

Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453

Arm I (xylitol dental wipe); Arm II (non-xylitol dental wipe)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (xylitol dental wipe); Arm II (non-xylitol dental wipe)

Placebo Administration DRUG

Given intraorally

Arm II (non-xylitol dental wipe)

Xylitol-containing Oral Wipe OTHER

Given intraorally

Also known as: Spiffies (TM) Xylitol Wipes, Xylitol Wipes

Arm I (xylitol dental wipe)

Biospecimen Collection PROCEDURE

Undergo saliva sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm I (xylitol dental wipe); Arm II (non-xylitol dental wipe)

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Oncology Group: lead

Study Sites (1)

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jennifer J Wilkes

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject, investigators, and site-specific research and clinical staff who are involved with the conduct of the study will remain blinded to the treatment. The presence of a BSI event (either single organism or polymicrobial) will be determined by review of microbiology reports submitted to a central review committee whose members will be blinded to treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 15, 2025
• Study Start: May 26, 2026
• Primary Completion (Estimated): January 15, 2032
• Study Completion (Estimated): January 15, 2033
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

US (1)