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

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047083
• Other study ID #: 2215-MA-3074
• Status: Completed
• Start date: June 2, 2014
• Est. completion date: March 18, 2016

Study information

• Verified date: January 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1027
• Est. completion date: March 18, 2016
• Est. primary completion date: March 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sermo	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment patterns assessed by drugs initiated		Up to 3 years
Primary	Treatment patterns assessed by dosage		Up to 3 years
Primary	Treatment patterns assessed by duration of treatment		Up to 3 years
Primary	Treatment patterns assessed by whether remission was achieved.		Up to 3 years
Primary	Treatment patterns assessed by an event	Reported death, failure of treatment or relapse of any type	Up to 3 years
Primary	AML-related healthcare resource use assessed by number of hospitalizations and lengths of ICU hospital stay		Up to 3 years
Primary	AML-related healthcare resource use assessed by number of emergency department (ED) visits		Up to 3 years
Primary	AML-related healthcare resource use assessed by number of outpatient visits		Up to 3 years
Primary	AML-related healthcare resource use assessed by number of blood transfusions		Up to 3 years
Primary	AML-related healthcare resource use assessed by number of infections and associated treatments		Up to 3 years
Primary	AML-related healthcare resource use assessed by number of lab tests	Lab tests include bone marrow biopsy	Up to 3 years
Primary	AML-related healthcare resource use assessed by number of relevant concomitant medications		Up to 3 years
Primary	AML-related healthcare resource use assessed by number of diagnostic procedures		Up to 3 years
Primary	AML-related healthcare resource use assessed by use of mechanical ventilation		Up to 3 years
Primary	AML-related healthcare resource use assessed by use of parenteral feeding		Up to 3 years
Primary	AML-related healthcare resource use assessed by length of hospice care		Up to 3 years
Primary	AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)		Up to 3 years
Primary	AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU)		Up to 3 years