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

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Astellas

Status

Completed

Conditions

Acute Myeloid Leukemia (AML)

Treatments

Other: AML-related healthcare resources
Other: Treatment patterns among AML patients

Study type

Observational

Funder types

Industry

Identifiers

NCT03047083
2215-MA-3074

Details and patient eligibility

About

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 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.

Enrollment

1,027 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Exclusion criteria

Not applicable

Trial design

1,027 participants in 6 patient groups

IC eligible AML patients with FLT3 mutation
Description:
Newly diagnosed AML patients
Treatment:
Other: Treatment patterns among AML patients
Other: AML-related healthcare resources
IC ineligible patients with FLT3 mutation
Description:
Newly diagnosed AML patients
Treatment:
Other: Treatment patterns among AML patients
Other: AML-related healthcare resources
AML patients after R/R with FLT3 mutation
Description:
R/R are relapse/refractory patients
Treatment:
Other: Treatment patterns among AML patients
Other: AML-related healthcare resources
IC eligible patients without FLT3 mutation
Description:
Newly diagnosed AML patients
Treatment:
Other: Treatment patterns among AML patients
Other: AML-related healthcare resources
IC ineligible patients without FLT3 mutation
Description:
Newly diagnosed AML patients
Treatment:
Other: Treatment patterns among AML patients
Other: AML-related healthcare resources
AML patients after R/R without FLT3 mutation
Description:
R/R are relapse/refractory patients
Treatment:
Other: Treatment patterns among AML patients
Other: AML-related healthcare resources

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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