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

Description
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.

Objective
PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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.

Treatment 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.

Key Eligibility Inclusion Criteria:

- Patient must be >/= 1 year to - 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.

Applicable Disease Sites
Leukemia

Participating Institutions
American Family Children's Hospital (AFCH); Gundersen Health System; UW Health Eastpark Medical Center; UW Health University Hospital