N/A
N=610
Home Away From Home - Medical Outcomes
Acute Myeloid Leukemia · Neutropenia · Bacteremia
Bottom Line
View on ClinicalTrials.gov: NCT02774850 ↗Enrolled (actual)
610
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Occurrence of Post-chemotherapy Bacteremia — 22; 81 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Post-chemotherapy Bacteremia |
22; 81 | — |
| SECONDARY Time to the Initiation of the Next Chemotherapy Course |
31.5; 27.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Patients being treated for relapsed AML
- Patients with Acute Promyelocytic Leukemia (APML)
- Patients undergoing stem cell transplant (SCT)
- Patients receiving reduced intensity frontline chemotherapy
Data sourced from ClinicalTrials.gov (NCT02774850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.