Home Away From Home - Medical Outcomes (Aim 1)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Neutropenia; Bacteremia

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.

• Study Type: Observational
• Enrollment (Actual): 610

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital of Colorado
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I duPont Hospital for Children
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute/Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C.S. Mott Children's Hospital
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center of Dallas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Primary Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all AML patients who received or will receive chemotherapy between January 1, 2012 and December 31, 2019 at any of the fifteen participating pediatric institutions across the US. Patients discharged within 3 days after completion of that chemotherapy course will be categorized as 'early discharge' to outpatient management during neutropenia. Patients meeting eligibility criteria for 'early discharge' but remaining in the hospital more than 3 days after completion of that chemotherapy course will be categorized as inpatient management. Patients will be considered early discharge-eligible if there is no evidence of fever, infection or intensive care unit (ICU) level care within ± 3 days of the last dose of chemotherapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Early Discharge Management; Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
Inpatient Management; Remain hospitalized during chemotherapy-induced neutropenia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 26, 2019
• Study Completion (Actual): July 26, 2019

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Pediatric; Chemotherapy; Neutropenia Management; Chart Abstraction
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Neoplasms by Histologic Type; Neoplasms; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Agranulocytosis; Leukopenia; Leukocyte Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neutropenia; Bacteremia
• Other Study ID Numbers: 15-012074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Coded, limited data sets will be shared with participating sites upon approved request. Only aggregate level data will be shared with the study sponsor Patient-Centered Outcomes Research Institute (PCORI).