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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: May 26, 2026 to Aug 14, 2026 Trial sites expanded: 36 → 39 locationsv11 Show 1 more changeShow less
    • Trial sites expanded: 36 → 39 locations
  2. Trial sites expanded: 28 → 36 locationsv10
  3. Trial sites expanded: 24 → 28 locationsv9
  4. Trial sites expanded: 1 → 24 locationsv8
  5. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Oct 25, 2026 to May 26, 2026v7 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 25, 2026 to May 26, 2026
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Aug 8, 2026 to Oct 25, 2026v6
  2. Start date: Jun 1, 2026 to Aug 8, 2026 Secondary endpoints: details revised at 1 of 1 entryv5 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Primary completion date: Jun 30, 2031 to Jan 15, 2032 Start date: Jan 20, 2026 to Jun 1, 2026 · Completion date: Jun 30, 2032 to Jan 15, 2033v4 Show 2 more changesShow less
    • Start date: Jan 20, 2026 to Jun 1, 2026
    • Completion date: Jun 30, 2032 to Jan 15, 2033
  4. Primary completion date: Dec 1, 2030 to Jun 30, 2031 Start date: Nov 18, 2025 to Jan 20, 2026 · Completion date: Dec 1, 2030 to Jun 30, 2032v3 Show 2 more changesShow less
    • Start date: Nov 18, 2025 to Jan 20, 2026
    • Completion date: Dec 1, 2030 to Jun 30, 2032
  5. Secondary endpoints: details revised at 1 of 1 entryv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07022678
Lead Sponsor Children's Oncology Group
Conditions Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
Enrollment 556 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov