Home Away From Home - Medical Outcomes

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.

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Key information

Conditions

Acute Myeloid Leukemia Agranulocytosis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Infections Inflammation Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Histologic Type Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Occurrence of Post-chemotherapy Bacteremia

Time frame: 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.

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.

Secondary outcomes

Time to the Initiation of the Next Chemotherapy Course

Time frame: The number of days from the three days after the completion chemotherapy in a given course until the first day of the next 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

Alfred I. duPont Hospital for Children
Ann & Robert H Lurie Children's Hospital of Chicago
Arkansas Children's Hospital Research Institute
Baylor College of Medicine
C.S. Mott Children's Hospital
Children's Healthcare of Atlanta
Children's Hospital Colorado
Children's Hospital of Michigan
Children's Medical Center Dallas
Dana-Farber Cancer Institute
Lucile Packard Children's Hospital
Ochsner Health System
Patient-Centered Outcomes Research Institute
Primary Children's Hospital
Rady Children's Hospital, San Diego
Seattle Children's Hospital
University of Mississippi Medical Center

Registry information

Official study title

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

Acronym: Aim 1

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: May 17, 2016
Registry last updated: Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed