NCT06463639Completed
FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia
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
Source: ClinicalTrials.gov · Last updated 20 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1213 (actual)
- First submitted
- 12 Jun 2024
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06463639
What you commit to
- Study type: Observational
- Participants enrolled: 1213
- From 1 Jan 2022 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.