Home Away From Home - Medical Outcomes

Study Overview
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Brief Summary
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Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. Infectious complications are the leading cause of treatment related mortality among AML patients, but there are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The primary objective of this study is to compare the clinical effectiveness of outpatient versus inpatient management of neutropenia in children with AML.

Detailed Description
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This is a bidirectional observational cohort study. Participants will be patients less that 19 years of age at diagnosis receiving or having received chemotherapy for AML from seventeen participating pediatric hospitals across the United States. There is no study intervention; this is a medical record abstraction study only. Investigators will abstract subjects medical record data over the study period in order to study clinical outcomes including the occurrence of bacteremia and time to the start of the next course in the chemotherapy regimen, in relation to neutropenia management strategy.

Official Title
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Home or Away From Home: Comparing Clinical Outcomes Relevant to the Care of Pediatric Acute Myeloid Leukemia During Periods of Neutropenia

Conditions
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Acute Myeloid Leukemia, Neutropenia, Bacteremia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females of age less than 19 at diagnosis. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019. Exclusion Criteria: Patients being treated for relapsed AML Patients with Acute Promyelocytic Leukemia (APML) Patients undergoing stem cell transplant (SCT) Patients receiving reduced intensity frontline chemotherapy

Ages Eligible for Study
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Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Discharge Management<br>Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course | |
| Inpatient Management<br>Remain hospitalized during chemotherapy-induced neutropenia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Post-chemotherapy Bacteremia | Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia. | Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the Initiation of the Next Chemotherapy Course | Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course. | The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Neutropenia Management, Acute Myeloid Leukemia, Chart Abstraction, Chemotherapy