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
1 other identifier
observational
610
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedResults Posted
Study results publicly available
December 23, 2019
CompletedDecember 23, 2019
December 1, 2019
4.2 years
May 13, 2016
September 4, 2019
December 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time to the Initiation of the Next Chemotherapy 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
Study Arms (2)
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
Eligibility Criteria
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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- C.S. Mott Children's Hospitalcollaborator
- Children's Healthcare of Atlantacollaborator
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
- Children's Medical Center Dallascollaborator
- Children's Hospital of Michigancollaborator
- Baylor College of Medicinecollaborator
- University of Mississippi Medical Centercollaborator
- Arkansas Children's Hospital Research Institutecollaborator
- Ochsner Health Systemcollaborator
- Lucile Packard Children's Hospitalcollaborator
- Primary Children's Hospitalcollaborator
- Rady Children's Hospital, San Diegocollaborator
- Seattle Children's Hospitalcollaborator
- Patient-Centered Outcomes Research Institutecollaborator
- Children's Hospital Coloradocollaborator
- Alfred I. duPont Hospital for Childrencollaborator
- Dana-Farber Cancer Institutecollaborator
Study Sites (17)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Alfred I DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Ann & Robert H Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Dana-Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, 02215, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84132, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard Aplenc
- Organization
- Children's Hospital of Philadelphia
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Aplenc, MD, PhD
Children's Hospital of Philadelphia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2016
First Posted
May 17, 2016
Study Start
June 1, 2015
Primary Completion
July 26, 2019
Study Completion
July 26, 2019
Last Updated
December 23, 2019
Results First Posted
December 23, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share
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).