Home Away From Home - Medical Outcomes

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Home or Away From Home: Comparing Clinical Outcomes Relevant to the Care of Pediatric Acute Myeloid Leukemia During Periods of Neutropenia

ClinicalTrials.gov ID

NCT02774850

Acronym / sponsor ID

Aim 1 / 15-012074

Conditions

Acute Myeloid Leukemia, Neutropenia, Bacteremia

Keywords

Pediatric, Neutropenia Management, Acute Myeloid Leukemia, Chart Abstraction, Chemotherapy

Study type

Observational

Recruitment status

Completed

Enrolment

610 participants (actual)

Lead sponsor

Children's Hospital of PhiladelphiaUniversity, hospital or other

Collaborators

C.S. Mott Children's Hospital, Children's Healthcare of Atlanta, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Medical Center Dallas, Children's Hospital of Michigan, Baylor College of Medicine, University of Mississippi Medical Center, Arkansas Children's Hospital Research Institute, Ochsner Health System, Lucile Packard Children's Hospital, Primary Children's Hospital, Rady Children's Hospital, San Diego, Seattle Children's Hospital, Patient-Centered Outcomes Research Institute, Children's Hospital Colorado, Alfred I. duPont Hospital for Children, Dana-Farber Cancer Institute

Study start

Jun 2015

Primary completion

26 Jul 2019 (actual)

Study completion

26 Jul 2019 (actual)

First posted

17 May 2016 (estimated)

Results

Posted 23 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Other

Number of arms

2

Who may qualify

Ages

Up to 19 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult

Study population

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Occurrence of Post-chemotherapy Bacteremia

   Time frame: 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.

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: No. 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).

Related trials for Acute Myeloid Leukemia

• Not yet recruitingPhase 1/2

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  Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

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• RecruitingPhase 2

  MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

  Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm

• RecruitingPhase 2

  Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

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• RecruitingPhase 2

  Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases

  Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

17 sites in 1 country: see every site and its status.