Home Away From Home - Medical Outcomes

Acute Myeloid Leukemia Clinical Trial

— Aim 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774850
• Other study ID #: 15-012074
• Status: Completed
• Start date: June 2015
• Est. completion date: July 26, 2019

Study information

• Verified date: December 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: July 26, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

Inclusion Criteria:

1. Males or females of age less than 19 at diagnosis.

2. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019.

Exclusion Criteria:

1. Patients being treated for relapsed AML

2. Patients with Acute Promyelocytic Leukemia (APML)

3. Patients undergoing stem cell transplant (SCT)

4. Patients receiving reduced intensity frontline chemotherapy

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Bacteremia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neutropenia

Locations

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

Sponsors (18)

Lead Sponsor

Collaborator

Children's Hospital of Philadelphia

Alfred I. duPont Hospital for Children, Ann & Robert H Lurie Children's Hospital of Chicago, Arkansas Children's Hospital Research Institute, 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, Texas Children's Hospital, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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