Clinical trial NCT03047083: Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia (AML) With or Without FMS-like Tyrosine Kinase-3 (FLT3) Mutation Study Based on Retrospective Chart Review
Official title: Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia With and Without FLT3 Mutation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Retrospective
Non-interventional Study
FMS-like tyrosine kinase-3 (FLT3) mutations
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-02-08
Enrollment: 1027
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult AML patients with or without FLT3 mutation under or previously under the care of participating physicians.

Brief summary: The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.

Detailed description: The current study is a retrospective non-interventional study using real-world data collected from existing medical records to evaluate descriptively the treatment patterns and key healthcare resource use among AML patients with or without FLT3 mutation. The current study relies on secondary use of existing data, and there is no intervention involved. Patients who received the first AML treatment after the initial diagnosis, or were classified as relapsed/refractory (R/R), between January 1, 2013 and December 31, 2015 will be randomly selected to be included in this study, and the data from their existing medical records will be extracted. Eligible patients will be grouped based on FLT3 mutation status, intensive chemotherapy (IC) eligibility, and R/R status.

For newly diagnosed patients, the index date will be defined as the initiation date of the first AML treatment following initial diagnosis. For the R/R patients, the index date will be defined as the date of the patient being classified as R/R. The study period will be the period from the index date to last follow-up date or death, whichever comes earlier. The endpoint measurements of this study are treatment patterns and key AML-related healthcare resources used during the study period.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of AML but NOT acute promyelocytic leukemia (APL)
* Known FLT3 mutation status
* Under the care of the participating physician during the past 3 years OR from the initial diagnosis of AML
* The medical records related to AML for the patient are available to the physician and can be abstracted for this study
* The medical records contains complete information on treatments and AML-related hospitalization, including admission date, length of stay, and reason of hospitalization
* Initiation date of first treatment after AML diagnosis OR date of being classified as relapsed from or being refractory to initial treatment (R/R) is between January 1, 2013 and December 31, 2015

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Treatment patterns assessed by drugs initiated
timeFrame: Up to 3 years
measure: Treatment patterns assessed by dosage
timeFrame: Up to 3 years
measure: Treatment patterns assessed by duration of treatment
timeFrame: Up to 3 years
measure: Treatment patterns assessed by whether remission was achieved.
timeFrame: Up to 3 years
measure: Treatment patterns assessed by an event
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of hospitalizations and lengths of ICU hospital stay
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of emergency department (ED) visits
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of outpatient visits
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of blood transfusions
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of infections and associated treatments
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of lab tests
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of relevant concomitant medications
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of diagnostic procedures
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by use of mechanical ventilation
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by use of parenteral feeding
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by length of hospice care
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
timeFrame: Up to 3 years
measure: AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU)
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Sermo
state: North Carolina
Study officials:
affiliation: Astellas Medical Affairs, Global
name: Astellas Medical Affairs, Global
role: STUDY_DIRECTOR
References: