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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia (AML)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1027

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Sermo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult AML patients with or without FLT3 mutation under or previously under the care of participating physicians.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Reported death, failure of treatment or relapse of any type	Up to 3 years
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	Lab tests include bone marrow biopsy	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 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

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.
• Investigators: Study Director: Astellas Medical Affairs, Global, Astellas Medical Affairs, Global

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2014
• Primary Completion (Actual): March 18, 2016
• Study Completion (Actual): March 18, 2016

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Non-interventional Study; Retrospective; FMS-like tyrosine kinase-3 (FLT3) mutations
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 2215-MA-3074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."