FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia

NCT06463639 | Completed

• 1 other identifier: 202203013RSD
• Study Type: observational
• Target: 1,213
• Locations: 1 country
• Sites: 1

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 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

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia; FLT3; Clonal evolution

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Determine FLT3 mutation prevalence at diagnosis

  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.

  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.

  From date of diagnosis until the date of death from any cause, assessed up to 30 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

FLT3 testing was introduced in NTUH since 2000 and became a standard test since 2015, while MRD testing became standard and widely used since 2009. Thus, eligible patients for the R/R cohort and the newly diagnosed cohort will be identified between the period of 1 January 2009 and 31 December 2019.

You may qualify if:

• Relapsed/refractory cohort:
• \. Adult patient (age ≥18 years) diagnosed with non-M3 primary AML (confirmed diagnosis using WHO 2016 criteria within the NTUH-AML dataset) who:
• First experienced refractory disease (failure to achieve complete remission or complete remission with incomplete hematologic recovery) to 2 cycles of induction therapy between 1 January 2009 and 31 December 2019, OR
• First experienced hematological relapse after a CR between 1 January 2009 and 31 December 2019. Patient with bone marrow blasts ≥5 %, reappearance of blasts in the blood, or development of extramedullary disease after achieving remission is defined to have relapse of AML.
• Newly diagnosed cohort:
• Adult patient (age ≥ 18 years) newly diagnosed with non-M3 primary AML (confirmed diagnosis using WHO 2016 criteria within the NTUH-AML dataset) between 1 January 2009 and 31 December 2019.

You may not qualify if:

• Relapsed/refractory cohort:
• Patient with M3 subtype (acute promyelocytic leukemia, APL)
• Patient with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN)
• Patient without any FLT3 records
• Patient with secondary or therapy-related AML
• Newly diagnosed cohort:
• Patient with M3 subtype (APL)
• Patient with prior history of MDS or MPN
• Patient without any FLT3 records
• Patient with secondary or therapy-related AML

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: January 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: June 10, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

TW (1)