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Acute Myeloid Leukemia / Recurrent Acute Myeloid Leukemia / Cytarabine · Phase 3 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial currently recruiting to evaluate whether xylitol-containing oral wipes reduce bloodstream infections from oral flora in children with acute myeloid leukemia undergoing chemotherapy. No results have been posted in this registry record; the trial is actively enrolling and outcomes remain pending.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Supportive Care purpose. Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia; age from 1 Year; to 25 Years. Intervention: Arm I (xylitol dental wipe). Compared with: Arm II (non-xylitol dental wipe) — Active Comparator. n = 556. 39 sites: United States.
This is a Phase 3 randomized controlled trial currently recruiting to evaluate whether xylitol-containing oral wipes reduce bloodstream infections from oral flora in children with acute myeloid leukemia undergoing chemotherapy. No results have been posted in this registry record; the trial is actively enrolling and outcomes remain pending.
This is a registry record only; no efficacy or safety results are reported.
The source did not state who this applies to in practice.
This is an active Phase 3 trial registration with no results posted; the study design is sound but outcome data are not yet available, making any evidence claim premature.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07022678). This is a study registration, not published results. Lead sponsor: Children's Oncology Group. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 556 participants (ESTIMATED). Conditions: Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia. Interventions: OTHER: Best Practice; PROCEDURE: Biospecimen Collection; DRUG: Cytarabine; OTHER: Electronic Health Record Review; DRUG: Placebo Administration; OTHER: Xylitol-containing Oral Wipe. Primary outcome measures: Number of bloodstream infections (BSI) from oral flora , Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.