FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia
NCT Number: NCT06463639
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Myeloid Leukemia
Sponsor: National Taiwan University Hospital
Collaborators: Astellas Pharma Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1213
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-06-10
Locations: National Taiwan University Hospital, Taipei, 100, Taiwan

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 relapsed/refractory disease (R/R 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 R/R 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 R/R 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 R/R AML evidence for the R/R 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 study's end, loss to follow-up, or death.

Primary Outcome Measures: Estimate FLT3 testing turnaround time in clinical practice., This outcome measure focuses on determining the average time required to complete FLT3 testing from the point of sample collection to the delivery of results in a real-world clinical setting. The goal is to evaluate the efficiency and speed of the current FLT3 testing processes. By estimating the turnaround time, the investigators aim to identify potential delays and areas for improvement to ensure timely initiation of targeted therapies for patients with acute myeloid leukemia (AML). This data will provide valuable insights into the operational aspects of FLT3 testing and its alignment with clinical practice guidelines., From date of diagnosis until the date of death from any cause, assessed up to 30 years|Assess FLT3 clonal evolution in the relapsed/refractory cohort., This outcome measure involves analyzing the changes in FLT3 mutation status in patients with relapsed or refractory acute myeloid leukemia (AML). The study aims to track the presence, loss, or acquisition of FLT3 mutations over the course of the disease. By examining FLT3 clonal evolution, the investigators aim to better understand how these genetic changes correlate with disease progression, treatment response, and overall patient outcomes. The results will provide insights into the dynamics of FLT3 mutations and inform future therapeutic strategies., From date of diagnosis until the date of death from any cause, assessed up to 30 years
Secondary Outcome Measures: Determine FLT3 mutation prevalence at diagnosis, This outcome measure aims to establish the prevalence of FLT3 mutations in patients newly diagnosed with acute myeloid leukemia (AML). By identifying the proportion of patients who test positive for FLT3 mutations at the time of diagnosis, the investigators can better understand the genetic landscape of AML within the study population. This data is crucial for assessing the potential impact of FLT3-targeted therapies and for tailoring treatment strategies according to mutation status, From date of diagnosis until the date of death from any cause, assessed up to 30 years|Evaluate the association of FLT3 mutation changes with treatment discontinuation and overall survival (OS) in the relapsed/refractory cohort., This outcome measure investigates how changes in FLT3 mutation status (acquisition, loss, or maintenance) are associated with treatment discontinuation and overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (AML). By examining the relationship between FLT3 clonal evolution and clinical outcomes, the investigators aim to determine the prognostic significance of these genetic changes., From date of diagnosis until the date of death from any cause, assessed up to 30 years|Investigate the link between Measurable Residual Disease (MRD) outcomes with treatment discontinuation and OS in the newly diagnosed cohort., This outcome measure examines the relationship between Measurable Residual Disease (MRD) status and key clinical outcomes, specifically treatment discontinuation and overall survival (OS), in patients newly diagnosed with acute myeloid leukemia (AML). By assessing MRD levels at various stages of treatment, the investigators aim to determine how residual disease impacts the likelihood of continuing therapy and the overall prognosis., From date of diagnosis until the date of death from any cause, assessed up to 30 years