Gluten Free Diet in Diminishing Side Effects Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy

PRIMARY OBJECTIVES:

I. To determine if a gluten free diet (GFD) modulates the rate and severity of bacteremia and
gastrointestinal toxicity (measured by total parenteral nutrition [TPN] or nothing by mouth
[NPO] order) in patients undergoing standard acute myeloid leukemia (AML) induction
chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the tolerance of, and compliance with, a GFD in patients undergoing standard
AML induction chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy
standards from the initiation of induction chemotherapy until hospital discharge
(approximately 30 days). Patients also complete a daily food intake diary. A stool sample is
collected from patients at baseline, day 14, and on the day of hospital discharge for gut
microbiome analysis.

GROUP II: Patients receive a standard diet for from the initiation of induction chemotherapy
until hospital discharge (approximately 30 days). Patients also complete a daily food intake
diary. A stool sample is collected from patients at baseline, day 14, and on the day of
hospital discharge for gut microbiome analysis.

Inclusion Criteria:

- Patients undergoing AML induction chemotherapy with an anthracycline +
cytarabine-based chemotherapy regimen

- No history of celiac disease or non-celiac gluten sensitivity

- No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening

- No documented bacteremia at time of initial screening

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at time of
initial screening

Exclusion Criteria:

- Pregnant women