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: