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

NCT ID: NCT03047083

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1027 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-02

Study Completion Date

2016-03-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IC eligible AML patients with FLT3 mutation

Newly diagnosed AML patients

Treatment patterns among AML patients

Intervention Type 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

Intervention Type 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.

IC ineligible patients with FLT3 mutation

Newly diagnosed AML patients

Treatment patterns among AML patients

Intervention Type 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

Intervention Type 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 patients after R/R with FLT3 mutation

R/R are relapse/refractory patients

Treatment patterns among AML patients

Intervention Type 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

Intervention Type 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.

IC eligible patients without FLT3 mutation

Newly diagnosed AML patients

Treatment patterns among AML patients

Intervention Type 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

Intervention Type 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.

IC ineligible patients without FLT3 mutation

Newly diagnosed AML patients

Treatment patterns among AML patients

Intervention Type 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

Intervention Type 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 patients after R/R without FLT3 mutation

R/R are relapse/refractory patients

Treatment patterns among AML patients

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astellas Medical Affairs, Global

Role: STUDY_DIRECTOR

Astellas Medical Affairs, Global

Locations

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Sermo

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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2215-MA-3074

Identifier Type: -

Identifier Source: org_study_id

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