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FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia

NCT06463639 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1213

Last updated 2024-06-20

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-10-31
Completion
2024-06-10

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463639 on ClinicalTrials.gov