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Conditions studied: Acute Myeloid Leukemia, Neutropenia, Bacteremia

In brief

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.

Key facts

Study ID

NCT02774850

Run by

Children's Hospital of Philadelphia

People needed

610

Starts

2015-06-01

Expected to finish

2019-07-26

Last updated by the study team

2019-12-23

Who can join

Age: any, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients being treated for relapsed AML
• Patients with Acute Promyelocytic Leukemia (APML)
• Patients undergoing stem cell transplant (SCT)
• Patients receiving reduced intensity frontline chemotherapy

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Lucile Packard Children's Hospital — Palo Alto, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Alfred I DuPont Hospital for Children — Wilmington, Delaware, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H Lurie Children's Hospital — Chicago, Illinois, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Dana-Farber Cancer Institute/Boston Children's Hospital — Boston, Massachusetts, United States
• C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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