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Acute Myeloid LeukemiaPhase 3NCT07022678

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

A Phase 3 study testing Best Practice, Biospecimen Collection and Cytarabine in people with Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, run by Children's Oncology Group at 39 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 25 years
What is being tested?
Best Practice, Biospecimen Collection and Cytarabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
556 participants
Where
39 sitesUnited States
Study dates
14 Aug 2026to 15 Jan 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

39 sites in 1 country. Contact the study team or a site near you to ask about taking part.

39 sites in 1 country

United States39 sites, 39 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Site Public Contact, 518-262-5513

    Lauren R. Weintraub

    Recruiting

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-559-6113, wburman@phs.org

    Beeling Armijo

    Recruiting

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125

    Joshua W. Goldman

    Recruiting

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, 30329

    Site Public Contact, 404-785-0232, Olivia.Floyd@choa.org

    Tamara P. Miller

    Recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

    Site Public Contact, 512-628-1902, TXAUS-DL-SFCHemonc.research@ascension.org

    Shannon M. Cohn

    Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

    Site Public Contact, 205-638-9285, oncologyresearch@peds.uab.edu

    Aman Wadhwa

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Brian C. Belyea

    Recruiting

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

    Site Public Contact, 773-880-4562

    Sara Zarnegar-Lumley

    Recruiting

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

    Site Public Contact, 216-844-5437

    Duncan S. Stearns

    Recruiting

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

    Site Public Contact, 361-694-5311, Crystal.DeLosSantos@dchstx.org

    Nkechi I. Mba

    Recruiting

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

    Site Public Contact, 972-566-5588

    Maurizio L. Ghisoli

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Gabriella Nguyen

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Jagadeesh Ramdas

    Recruiting

  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

    Denver, Colorado, 80218

    Site Public Contact, 303-832-2344, PSGResearchSharedMailbox@HCAHealthcare.com

    Florence Choo

    Recruiting

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-8912, samantha.mallory@unitypoint.org

    Samantha L. Mallory

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Samuel J. Milanovich

    Recruiting

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

    Site Public Contact, 239-343-5333, molly.arnstrom@leehealth.org

    Emad K. Salman

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Catherine A. Long

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

    Site Public Contact, 865-541-8266

    Susan E. Spiller

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    James T. Badgett

    Not yet recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

    Site Public Contact, 501-364-7373

    Michael W. Bishop

    Recruiting

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

    Site Public Contact, 502-629-5500, CancerResource@nortonhealthcare.org

    Michael J. Ferguson

    Recruiting

  • Valley Children's Hospital

    Madera, California, 93636

    Site Public Contact, 559-353-3000, Research@valleychildrens.org

    Ruetima Titapiwatanakun

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Cathy A. Lee-Miller

    Recruiting

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

    Site Public Contact, 615-342-1919

    Clinton M. Carroll

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

    Site Public Contact, 757-668-7243, CCBDCresearch@chkd.org

    Melissa S. Mark

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Aarati V. Rao

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, 32827

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Jeffrey H. Schwartz

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Site Public Contact, 267-425-5544, CancerTrials@email.chop.edu

    Rebecca Citrin

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-692-8570, jean.tersak@chp.edu

    Jean M. Tersak

    Recruiting

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Stanley Chaleff

    Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

    Site Public Contact, 800-228-6618, HopeBeginsHere@providence.org

    Judy L. Felgenhauer

    Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Alice Lee

    Recruiting

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Jamie L. Dargart

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the incidence rate of bloodstream infections (BSI) (BSI per 1000 patient-days) from oral organisms over 2 cycles of chemotherapy in children with acute myeloid leukemia (AML) randomized to xylitol-containing oral wipes (xylitol dental wipes) versus control wipes.

SECONDARY OBJECTIVE:

  1. To compare the rate of BSI (BSI per 1000 patient-days) from any organism in patients randomized to xylitol dental wipes versus control wipes.

EXPLORATORY OBJECTIVES:

  1. To compare the frequency of severe infection (defined as any infection or infestation falling under Common Terminology Criteria for Adverse Events [CTCAE] sepsis grade 4 or 5) in patients randomized to xylitol dental wipes versus control wipes.

II. To compare the frequency of fever and neutropenia episodes in patients randomized to xylitol dental wipes versus control wipes.

III. To compare the frequency of severe mucositis, using the Children's International Mucositis Evaluation Scale (ChIMES), in patients randomized to xylitol dental wipes versus control wipes in addition to CTCAE grade 3 and above mucositis.

IV. To evaluate changes in oral microbial composition in pediatric patients treated with xylitol versus control wipes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard chemotherapy containing cytarabine intravenously (IV) on study and receive a xylitol dental wipe intraorally twice daily (BID) to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until absolute neutrophil count (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.

ARM II: 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.

After completion of study treatment, patients are followed over the next cycle of chemotherapy or if chemotherapy is complete, for 90 days after the start of the last cycle of chemotherapy.

Being tested
Best Practice, Biospecimen Collection, Cytarabine, Electronic Health Record Review, Placebo Administration
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Given standard chemotherapy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo saliva sample collection

  • CytarabineDrug

    Also called .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

    Given IV

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Placebo AdministrationDrug

    Given intraorally

  • Xylitol-containing Oral WipeOther

    Also called Spiffies (TM) Xylitol Wipes, Xylitol Wipes

    Given intraorally

Study groups in NCT07022678
Study groupRoleWhat they receive
Arm I (xylitol dental wipe)ExperimentalPatients 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.
Receives: 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 comparatorPatients 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.
Receives: Other: Best Practice; Procedure: Biospecimen Collection; Drug: Cytarabine; Other: Electronic Health Record Review; Drug: Placebo Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Number of BSI from any organism

    Will report the estimated 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 BSI for the treatment relative to control arm and the corresponding 95% confidence interval.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start14 Aug 2026
  3. Primary completion15 Jan 2032 (estimated)
  4. Study completion15 Jan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
556 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07022678
Sponsor's protocol ID
ACCL2531
Other IDs
NCI-2025-03832, ACCL2531, COG-ACCL2531, ACCL2531, U24CA196173, UG1CA189955
Status last verified
Sep 2026
First submitted
29 May 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Best Practice, Biospecimen Collection and Cytarabine in people with Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, run by Children's Oncology Group at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of bloodstream infections (BSI) from oral flora (time frame: Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07022678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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