Home Away From Home - Medical Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Infectious Disease, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | Any - 19 |
| Updated: | 9/7/2018 |
| Start Date: | June 2015 |
| End Date: | December 2019 |
| Contact: | Richard Aplenc, MD, PhD |
| Email: | aplenc@chop.edu |
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.
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.
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.
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.
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
We found this trial at
17
sites
Boston, Massachusetts 02115
Phone: 617-632-4688
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 267-426-7252
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