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NCT Number: NCT03047083

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

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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sermo

Charlotte, North Carolina, 28209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment patterns among AML patients

Other

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-related healthcare resources

Other

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.

Primary outcomes

  1. Treatment patterns assessed by drugs initiated

    Time frame: Up to 3 years

  2. Treatment patterns assessed by dosage

    Time frame: Up to 3 years

  3. Treatment patterns assessed by duration of treatment

    Time frame: Up to 3 years

  4. Treatment patterns assessed by whether remission was achieved.

    Time frame: Up to 3 years

  5. Treatment patterns assessed by an event

    Time frame: Up to 3 years

    Reported death, failure of treatment or relapse of any type

  6. AML-related healthcare resource use assessed by number of hospitalizations and lengths of ICU hospital stay

    Time frame: Up to 3 years

  7. AML-related healthcare resource use assessed by number of emergency department (ED) visits

    Time frame: Up to 3 years

  8. AML-related healthcare resource use assessed by number of outpatient visits

    Time frame: Up to 3 years

  9. AML-related healthcare resource use assessed by number of blood transfusions

    Time frame: Up to 3 years

  10. AML-related healthcare resource use assessed by number of infections and associated treatments

    Time frame: Up to 3 years

  11. AML-related healthcare resource use assessed by number of lab tests

    Time frame: Up to 3 years

    Lab tests include bone marrow biopsy

  12. AML-related healthcare resource use assessed by number of relevant concomitant medications

    Time frame: Up to 3 years

  13. AML-related healthcare resource use assessed by number of diagnostic procedures

    Time frame: Up to 3 years

  14. AML-related healthcare resource use assessed by use of mechanical ventilation

    Time frame: Up to 3 years

  15. AML-related healthcare resource use assessed by use of parenteral feeding

    Time frame: Up to 3 years

  16. AML-related healthcare resource use assessed by length of hospice care

    Time frame: Up to 3 years

  17. AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)

    Time frame: Up to 3 years

  18. AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU)

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2017
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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