Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
610 participants
OBSERVATIONAL
2015-06-30
2019-07-26
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Early Discharge Management
Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
No interventions assigned to this group
Inpatient Management
Remain hospitalized during chemotherapy-induced neutropenia
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019.
Exclusion Criteria
2. Patients with Acute Promyelocytic Leukemia (APML)
3. Patients undergoing stem cell transplant (SCT)
4. Patients receiving reduced intensity frontline chemotherapy
19 Years
ALL
No
Sponsors
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C.S. Mott Children's Hospital
OTHER
Children's Healthcare of Atlanta
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Children's Medical Center Dallas
OTHER
Children's Hospital of Michigan
OTHER
Baylor College of Medicine
OTHER
University of Mississippi Medical Center
OTHER
Arkansas Children's Hospital Research Institute
OTHER
Ochsner Health System
OTHER
Lucile Packard Children's Hospital
OTHER
Primary Children's Hospital
OTHER
Rady Children's Hospital, San Diego
OTHER
Seattle Children's Hospital
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital Colorado
OTHER
Alfred I. duPont Hospital for Children
OTHER
Dana-Farber Cancer Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Richard Aplenc, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-012074
Identifier Type: -
Identifier Source: org_study_id