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

Sponsor

Astellas Pharma Global Development, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03047083

Collaborator

(none)

1,027

Enrollment

Location

21.5

Actual Duration (Months)

47.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Other: Treatment patterns among AML patients Other: AML-related healthcare resources

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1027 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia With and Without FLT3 Mutation

Actual Study Start Date :

Jun 2, 2014

Actual Primary Completion Date :

Mar 18, 2016

Actual Study Completion Date :

Mar 18, 2016

Arms and Interventions

Arm	Intervention/Treatment
IC eligible AML patients with FLT3 mutation Newly diagnosed AML patients	Other: Treatment patterns among AML patients This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. Other: AML-related healthcare resources This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
IC ineligible patients with FLT3 mutation Newly diagnosed AML patients	Other: Treatment patterns among AML patients This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. Other: AML-related healthcare resources This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
AML patients after R/R with FLT3 mutation R/R are relapse/refractory patients	Other: Treatment patterns among AML patients This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. Other: AML-related healthcare resources This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
IC eligible patients without FLT3 mutation Newly diagnosed AML patients	Other: Treatment patterns among AML patients This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. Other: AML-related healthcare resources This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
IC ineligible patients without FLT3 mutation Newly diagnosed AML patients	Other: Treatment patterns among AML patients This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. Other: AML-related healthcare resources This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
AML patients after R/R without FLT3 mutation R/R are relapse/refractory patients	Other: Treatment patterns among AML patients This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. Other: AML-related healthcare resources This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.

Outcome Measures

Primary Outcome Measures

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]
Treatment patterns assessed by whether remission was achieved. [Up to 3 years]
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]
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 outpatient visits [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 infections and associated treatments [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 relevant concomitant medications [Up to 3 years]
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 length of hospice care [Up to 3 years]
AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU) [Up to 3 years]
AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU) [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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