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Summary

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.

Conditions

Acute Myeloid Leukemia, Neutropenia, Bacteremia

Recruitment Status

Completed

Detailed Description

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.

Eligibility Criteria

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

Gender

All

Min Age

N/A

Max Age

19 Years

Download Date

December 23, 2019

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Home Away From Home - Medical Outcomes NCT02774850