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

Overview

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.

Full Title of Study: “Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia With and Without FLT3 Mutation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 18, 2016

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • IC eligible AML patients with FLT3 mutation
    • Newly diagnosed AML patients
  • IC ineligible patients with FLT3 mutation
    • Newly diagnosed AML patients
  • AML patients after R/R with FLT3 mutation
    • R/R are relapse/refractory patients
  • IC eligible patients without FLT3 mutation
    • Newly diagnosed AML patients
  • IC ineligible patients without FLT3 mutation
    • Newly diagnosed AML patients
  • AML patients after R/R without FLT3 mutation
    • R/R are relapse/refractory patients

Clinical Trial Outcome Measures

Primary Measures

  • Treatment patterns assessed by drugs initiated
    • Time Frame: Up to 3 years
  • Treatment patterns assessed by dosage
    • Time Frame: Up to 3 years
  • Treatment patterns assessed by duration of treatment
    • Time Frame: Up to 3 years
  • Treatment patterns assessed by whether remission was achieved.
    • Time Frame: Up to 3 years
  • Treatment patterns assessed by an event
    • Time Frame: 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
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by number of emergency department (ED) visits
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by number of outpatient visits
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by number of blood transfusions
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by number of infections and associated treatments
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by number of lab tests
    • Time Frame: Up to 3 years
    • Lab tests include bone marrow biopsy
  • AML-related healthcare resource use assessed by number of relevant concomitant medications
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by number of diagnostic procedures
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by use of mechanical ventilation
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by use of parenteral feeding
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by length of hospice care
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
    • Time Frame: Up to 3 years
  • AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU)
    • Time Frame: Up to 3 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Global Development, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Astellas Medical Affairs, Global, Study Director, Astellas Medical Affairs, Global

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