Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03047083
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2017-02-06
Brief Title:
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
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia With and Without FLT3 Mutation
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 RR status
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 relapsedrefractory RR 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 RR 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 RR patients the index date will be defined as the date of the patient being classified as RR 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
For newly diagnosed patients the index date will be defined as the initiation date of the first AML treatment following initial diagnosis For the RR patients the index date will be defined as the date of the patient being classified as RR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None