Acute Myeloid LeukemiaNCT06463639
FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 1,213 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Relapsed/refractory cohort:
- 1. 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Cohort Study of FLT3 Turnaround Time in Acute Myeloid Leukemia (AML) Patients and the Clonal Evolution of FLT3 in Relapse/Refractory AML Patients in National Taiwan University Hospital
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:
Read more
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.
Read the 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 3.06 in males and 2.18 in females per 100,000 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 and/or 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, it's 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 relapsed/refractory (R/R) AML patients at NTUH. It will also investigate the clinical characteristics and survival outcomes of both adult R/R AML and newly diagnosed AML patients.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, FLT3, Clonal evolution
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: 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.
Measured: 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.
Measured: From date of diagnosis until the date of death from any cause, assessed up to 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jan 2022
- Primary completion31 Oct 2023
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463639
- Sponsor's protocol ID
- 202203013RSD
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of FLT3 Turnaround Time in Acute Myeloid Leukemia (AML) Patients and the Clonal Evolution of FLT3 in Relapse/Refractory AML Patients in National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT06463639
- Acronym / sponsor ID
- 202203013RSD
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, FLT3, Clonal evolution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,213 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 3.06 in males and 2.18 in females per 100,000 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 and/or 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, it's 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 relapsed/refractory (R/R) AML patients at NTUH. It will also investigate the clinical characteristics and survival outcomes of both adult R/R AML and newly diagnosed AML patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Relapsed/refractory cohort:
- 1. Adult patient (age ≥18 years) diagnosed with non-M3 primary AML (confirmed diagnosis using WHO 2016 criteria within the NTUH-AML dataset) who:
- Newly diagnosed cohort:
Key exclusion criteria (10 listed)
- Relapsed/refractory cohort:
- Newly diagnosed cohort:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate FLT3 testing turnaround time in clinical practice.
Time frame: From date of diagnosis until the date of death from any cause, assessed up to 30 years
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.
Assess FLT3 clonal evolution in the relapsed/refractory cohort.
Time frame: From date of diagnosis until the date of death from any cause, assessed up to 30 years
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.
3 secondary outcomes
Determine FLT3 mutation prevalence at diagnosis
Time frame: 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.
Time frame: 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.
Time frame: From date of diagnosis until the date of death from any cause, assessed up to 30 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate FLT3 testing turnaround time in clinical practice. (time frame: From date of diagnosis until the date of death from any cause, assessed up to 30 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.