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NCT02774850 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 610

Last updated 2019-12-23

Study results available
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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.

Conditions

Sponsors & Collaborators

  • C.S. Mott Children's Hospital

    collaborator OTHER
  • Children's Healthcare of Atlanta

    collaborator OTHER
  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER
  • Children's Medical Center Dallas

    collaborator OTHER
  • Children's Hospital of Michigan

    collaborator OTHER
  • Baylor College of Medicine

    collaborator OTHER
  • University of Mississippi Medical Center

    collaborator OTHER
  • Arkansas Children's Hospital Research Institute

    collaborator OTHER
  • Ochsner Health System

    collaborator OTHER
  • Lucile Packard Children's Hospital

    collaborator OTHER
  • Primary Children's Hospital

    collaborator OTHER
  • Rady Children's Hospital, San Diego

    collaborator OTHER
  • Seattle Children's Hospital

    collaborator OTHER
  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Children's Hospital Colorado

    collaborator OTHER
  • Alfred I. duPont Hospital for Children

    collaborator OTHER
  • Dana-Farber Cancer Institute

    collaborator OTHER
  • Children's Hospital of Philadelphia

    lead OTHER

Principal Investigators

  • Richard Aplenc, MD, PhD · Children's Hospital of Philadelphia

Eligibility

Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-07-26
Completion
2019-07-26

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02774850 on ClinicalTrials.gov