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
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Other: Treatment patterns among AML patientsOther: AML-related healthcare resources
- Registration Number
- NCT03047083
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1027
- 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
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IC ineligible patients without FLT3 mutation AML-related healthcare resources Newly diagnosed AML patients IC ineligible patients without FLT3 mutation Treatment patterns among AML patients Newly diagnosed AML patients AML patients after R/R without FLT3 mutation Treatment patterns among AML patients R/R are relapse/refractory patients IC eligible AML patients with FLT3 mutation Treatment patterns among AML patients Newly diagnosed AML patients IC eligible AML patients with FLT3 mutation AML-related healthcare resources Newly diagnosed AML patients IC ineligible patients with FLT3 mutation Treatment patterns among AML patients Newly diagnosed AML patients AML patients after R/R with FLT3 mutation Treatment patterns among AML patients R/R are relapse/refractory patients IC ineligible patients with FLT3 mutation AML-related healthcare resources Newly diagnosed AML patients AML patients after R/R with FLT3 mutation AML-related healthcare resources R/R are relapse/refractory patients IC eligible patients without FLT3 mutation Treatment patterns among AML patients Newly diagnosed AML patients IC eligible patients without FLT3 mutation AML-related healthcare resources Newly diagnosed AML patients AML patients after R/R without FLT3 mutation AML-related healthcare resources R/R are relapse/refractory patients
- Primary Outcome Measures
Name Time Method Treatment patterns assessed by an event Up to 3 years Reported death, failure of treatment or relapse of any type
AML-related healthcare resource use assessed by number of hospitalizations and lengths of ICU hospital stay Up to 3 years Treatment patterns assessed by whether remission was achieved. Up to 3 years AML-related healthcare resource use assessed by number of emergency department (ED) visits Up to 3 years AML-related healthcare resource use assessed by number of infections and associated treatments Up to 3 years AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU) Up to 3 years Treatment patterns assessed by drugs initiated Up to 3 years Treatment patterns assessed by dosage Up to 3 years Treatment patterns assessed by duration of treatment Up to 3 years AML-related healthcare resource use assessed by number of outpatient visits Up to 3 years AML-related healthcare resource use assessed by number of relevant concomitant medications Up to 3 years AML-related healthcare resource use assessed by length of hospice care Up to 3 years AML-related healthcare resource use assessed by number of blood transfusions Up to 3 years AML-related healthcare resource use assessed by number of lab tests Up to 3 years Lab tests include bone marrow biopsy
AML-related healthcare resource use assessed by number of diagnostic procedures Up to 3 years AML-related healthcare resource use assessed by use of mechanical ventilation Up to 3 years AML-related healthcare resource use assessed by use of parenteral feeding Up to 3 years AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU) Up to 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sermo
🇺🇸Charlotte, North Carolina, United States