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| Name | Class |
|---|---|
| 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 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Discharge Management | Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course | ||
| Inpatient Management | Remain hospitalized during chemotherapy-induced neutropenia |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Post-chemotherapy Bacteremia | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the Initiation of the Next Chemotherapy Course | Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course. | The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Aplenc, MD, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Lucile Packard Children's Hospital |
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).
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610 patients reflects the total number of patients included in chart abstractions; from there exclusion criteria were applied to determine early discharge eligibility. They were assigned to Early Discharge Management and Inpatient Management by chemotherapy course, not by the overall treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric AML Patients | All patients included in chart abstractions. Exclusion criteria were applied to these patients to determine if they were early discharge eligible. Then they were assigned to outpatient-managed and inpatient-managed arms. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2019 |
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| 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 |
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| Palo Alto |
| California |
| 94304 |
| United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States |
| Alfred I DuPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
| Ann & Robert H Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Dana-Farber Cancer Institute/Boston Children's Hospital | Boston | Massachusetts | 02215 | United States |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84132 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Induction I | Patients whose Induction I course was included in chart abstractions. |
|
| Early Discharge Eligible at Induction I | Study population after early discharge criteria were applied at Induction I. |
|
| Induction II | Patients whose Induction II course was included in chart abstractions. |
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| Early Discharge Eligible at Induction II | Study population after early discharge criteria were applied at Induction II. |
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| Intensification I | Patients whose Intensification I course was included in chart abstractions. |
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| Early Discharge Eligible at Int I | Study population after early discharge criteria were applied at Intensification I. |
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| Intensification II | Patients whose Intensification II course was included in chart abstractions. |
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| Early Discharge Eligible at Int II | Study population after early discharge criteria were applied at Intensification II. |
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| Intensification III | Patients whose Intensification III course was included in chart abstractions. |
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| Early Discharge Eligible at Int III | Study population after early discharge criteria were applied at Intensification III. |
|
| COMPLETED | This milestone reflects the total early discharge-eligible study population in the overall study. |
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| NOT COMPLETED |
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These were the discharge eligible patients who either remained inpatient or were managed outpatient during study course Induction II.
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Discharge Management | Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course |
| BG001 | Inpatient Management | Remain hospitalized during chemotherapy-induced neutropenia |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Post-chemotherapy Bacteremia | 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. | Patients in study course Induction II analyzed for bacteremia for this course. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Time to the Initiation of the Next Chemotherapy Course | Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course. | Patients in Induction II who were analyzed for the amount of time (in days) it took for them to start their next chemotherapy course. | Posted | Mean | Standard Deviation | days | The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course |
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Adverse events were not monitored while chart abstractions began in December 2015 and were completed in July 2019. As this is an observational study, it was determined that adverse events were a non-issue.
There is no study intervention; this is a medical record abstraction study only, thus adverse events were not monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Discharge Management | Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Inpatient Management | Remain hospitalized during chemotherapy-induced neutropenia | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Aplenc | Children's Hospital of Philadelphia | 267-426-7252 | aplenc@email.chop.edu |
| Aug 27, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009503 | Neutropenia |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
|
| Male |
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| Black |
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| Asian |
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| Other |
|
| Not recorded in EMR |
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| Not Hispanic Ethnicity |
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