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New treatment option for Acute Myeloid Leukemia
Official title Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07022678
What this study is testing
What is Cytarabine?
Cytarabine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join 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...
- 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...
You likely can't join 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Madera, California, United States
- Oakland, California, United States
- Denver, Colorado, United States
- Wilmington, Delaware, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Grand Rapids, Michigan, United States
- Kalamazoo, Michigan, United States
- Albany, New York, United States
- The Bronx, New York, United States
- Cleveland, Ohio, United States
- Toledo, Ohio, United States
- Danville, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Madera, California, United States; Oakland, California, United States; Denver, Colorado, United States; Wilmington, Delaware, United States; Jacksonville, Florida, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.