Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463639
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-12
Brief Title:
FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Retrospective Cohort Study of FLT3 Turnaround Time in Acute Myeloid Leukemia AML Patients and the Clonal Evolution of FLT3 in RelapseRefractory AML Patients in National Taiwan University Hospital
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This retrospective cohort study aims to describe the current FLT3 testing landscape in Taiwan It includes two patient groups non-M3 primary AML patients with relapsedrefractory disease RR cohort and newly diagnosed non-M3 primary AML patients newly diagnosed cohort
Primary objectives
Estimate FLT3 testing turnaround time in clinical practice Assess FLT3 clonal evolution in the RR cohort
Secondary objectives
Determine FLT3 mutation prevalence Describe karyotypes co-mutations and allelic ratios in both cohorts Study European LeukemiaNet ELN risk in the newly diagnosed cohort Evaluate the association of FLT3 mutation changes with treatment discontinuation and overall survival OS in the RR cohort
Investigate the link between Measurable Residual Disease MRD outcomes with treatment discontinuation and OS in the newly diagnosed cohort
Data from the National Taiwan University Hospital integrated Medical Database NTUH-iMD and NTUH-AML dataset will be used The index date is the earliest RR AML evidence for the RR cohort and the initial AML diagnosis date for the newly diagnosed cohort A three-year baseline period will provide patient history and comorbidity information Patients will be followed until the studys end loss to follow-up or death
Primary objectives
Estimate FLT3 testing turnaround time in clinical practice Assess FLT3 clonal evolution in the RR cohort
Secondary objectives
Determine FLT3 mutation prevalence Describe karyotypes co-mutations and allelic ratios in both cohorts Study European LeukemiaNet ELN risk in the newly diagnosed cohort Evaluate the association of FLT3 mutation changes with treatment discontinuation and overall survival OS in the RR cohort
Investigate the link between Measurable Residual Disease MRD outcomes with treatment discontinuation and OS in the newly diagnosed cohort
Data from the National Taiwan University Hospital integrated Medical Database NTUH-iMD and NTUH-AML dataset will be used The index date is the earliest RR AML evidence for the RR cohort and the initial AML diagnosis date for the newly diagnosed cohort A three-year baseline period will provide patient history and comorbidity information Patients will be followed until the studys end loss to follow-up or death
Detailed Description:
Acute myeloid leukemia AML is a heterogeneous group of hematological diseases According to the Taiwan Cancer Registry Annual Report 859 new AML cases were diagnosed in Taiwan in 2018 with an age-standardized incidence rate of 306 in males and 218 in females per 100000 person-years
The FMS-like tyrosine kinase 3 gene FLT3 affects the proliferation and differentiation of stem cells or hematopoietic progenitor cells FLT3 mutations are found in 25-30 of newly diagnosed AML patients and are considered a negative prognostic factor remaining significant even after intensive chemotherapy andor stem cell transplant
Two critical issues for ensuring timely targeted therapy for FLT3 patients are the speed of FLT3 test turnaround and the use of tests at key time points Rapid turnaround times are necessary for early intervention with European LeukemiaNet ELN recommending results within 3 days However its unclear if this is achievable in real-world settings FLT3 mutation status evolves with 15-25 of patients losing and 13 acquiring the mutation at relapse Despite guidelines recommending FLT3 testing at diagnosis and relapse there is no consensus in Taiwan on its importance and timing
Some observational studies on AML in Taiwan have been conducted but provide limited information on the timing and turnaround of FLT3 testing in real-world practice
This study will describe the current FLT3 testing landscape including turnaround time and timing of tests among adult relapsedrefractory RR AML patients at NTUH It will also investigate the clinical characteristics and survival outcomes of both adult RR AML and newly diagnosed AML patients
The FMS-like tyrosine kinase 3 gene FLT3 affects the proliferation and differentiation of stem cells or hematopoietic progenitor cells FLT3 mutations are found in 25-30 of newly diagnosed AML patients and are considered a negative prognostic factor remaining significant even after intensive chemotherapy andor stem cell transplant
Two critical issues for ensuring timely targeted therapy for FLT3 patients are the speed of FLT3 test turnaround and the use of tests at key time points Rapid turnaround times are necessary for early intervention with European LeukemiaNet ELN recommending results within 3 days However its unclear if this is achievable in real-world settings FLT3 mutation status evolves with 15-25 of patients losing and 13 acquiring the mutation at relapse Despite guidelines recommending FLT3 testing at diagnosis and relapse there is no consensus in Taiwan on its importance and timing
Some observational studies on AML in Taiwan have been conducted but provide limited information on the timing and turnaround of FLT3 testing in real-world practice
This study will describe the current FLT3 testing landscape including turnaround time and timing of tests among adult relapsedrefractory RR AML patients at NTUH It will also investigate the clinical characteristics and survival outcomes of both adult RR AML and newly diagnosed AML patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None