Acute Myeloid Leukemia (AML)NCT03047083
Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia (AML) With or Without FMS-like Tyrosine Kinase-3 (FLT3) Mutation Study Based on Retrospective Chart Review
An observational study of Acute Myeloid Leukemia (AML), run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Treatment patterns among AML patients and AML-related healthcare resources
- How many people
- 1,027 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2014to 18 Mar 2016
- 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: Adult AML patients with or without FLT3 mutation under or previously under the care of participating physicians.
Who may be able to join
- Confirmed diagnosis of AML but NOT acute promyelocytic leukemia (APL)
- Known FLT3 mutation status
- Under the care of the participating physician during the past 3 years OR from the initial diagnosis of AML
- The medical records related to AML for the patient are available to the physician and can be abstracted for this study
- The medical records contains complete information on treatments and AML-related hospitalization, including admission date, length of stay, and reason of hospitalization
- Initiation date of first treatment after AML diagnosis OR date of being classified as relapsed from or being refractory to initial treatment (R/R) is between January 1, 2013 and December 31, 2015
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia With and Without FLT3 Mutation
The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.
Read the detailed description
The current study is a retrospective non-interventional study using real-world data collected from existing medical records to evaluate descriptively the treatment patterns and key healthcare resource use among AML patients with or without FLT3 mutation. The current study relies on secondary use of existing data, and there is no intervention involved. Patients who received the first AML treatment after the initial diagnosis, or were classified as relapsed/refractory (R/R), between January 1, 2013 and December 31, 2015 will be randomly selected to be included in this study, and the data from their existing medical records will be extracted. Eligible patients will be grouped based on FLT3 mutation status, intensive chemotherapy (IC) eligibility, and R/R status.
For newly diagnosed patients, the index date will be defined as the initiation date of the first AML treatment following initial diagnosis. For the R/R patients, the index date will be defined as the date of the patient being classified as R/R. The study period will be the period from the index date to last follow-up date or death, whichever comes earlier. The endpoint measurements of this study are treatment patterns and key AML-related healthcare resources used during the study period.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Treatment patterns among AML patients, AML-related healthcare resources
- Keywords
- Retrospective, Non-interventional Study, FMS-like tyrosine kinase-3 (FLT3) mutations
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment patterns among AML patientsOther
This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
AML-related healthcare resourcesOther
This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
| Study group | Role | What they receive |
|---|---|---|
| IC eligible AML patients with FLT3 mutation | Newly diagnosed AML patients Receives: Other: Treatment patterns among AML patients; Other: AML-related healthcare resources | |
| IC ineligible patients with FLT3 mutation | Newly diagnosed AML patients Receives: Other: Treatment patterns among AML patients; Other: AML-related healthcare resources | |
| AML patients after R/R with FLT3 mutation | R/R are relapse/refractory patients Receives: Other: Treatment patterns among AML patients; Other: AML-related healthcare resources | |
| IC eligible patients without FLT3 mutation | Newly diagnosed AML patients Receives: Other: Treatment patterns among AML patients; Other: AML-related healthcare resources | |
| IC ineligible patients without FLT3 mutation | Newly diagnosed AML patients Receives: Other: Treatment patterns among AML patients; Other: AML-related healthcare resources | |
| AML patients after R/R without FLT3 mutation | R/R are relapse/refractory patients Receives: Other: Treatment patterns among AML patients; Other: AML-related healthcare resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment patterns assessed by drugs initiated
Measured: Up to 3 years
Treatment patterns assessed by dosage
Measured: Up to 3 years
Treatment patterns assessed by duration of treatment
Measured: Up to 3 years
Treatment patterns assessed by whether remission was achieved.
Measured: Up to 3 years
Treatment patterns assessed by an event
Reported death, failure of treatment or relapse of any type
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of hospitalizations and lengths of ICU hospital stay
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of emergency department (ED) visits
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of outpatient visits
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of blood transfusions
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of infections and associated treatments
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of lab tests
Lab tests include bone marrow biopsy
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of relevant concomitant medications
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of diagnostic procedures
Measured: Up to 3 years
AML-related healthcare resource use assessed by use of mechanical ventilation
Measured: Up to 3 years
AML-related healthcare resource use assessed by use of parenteral feeding
Measured: Up to 3 years
AML-related healthcare resource use assessed by length of hospice care
Measured: Up to 3 years
AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
Measured: Up to 3 years
AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start2 Jun 2014
- Primary completion18 Mar 2016
- Study completion18 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astellas Medical Affairs, Global, Study director, Astellas Medical Affairs, Global
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047083
- Sponsor's protocol ID
- 2215-MA-3074
- Status last verified
- Oct 2024
- First submitted
- 6 Feb 2017
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia With and Without FLT3 Mutation
- ClinicalTrials.gov ID
- NCT03047083
- Acronym / sponsor ID
- 2215-MA-3074
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Retrospective, Non-interventional Study, FMS-like tyrosine kinase-3 (FLT3) mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 18 Mar 2016 (actual)
- Study completion
- 18 Mar 2016 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.
Detailed description
The current study is a retrospective non-interventional study using real-world data collected from existing medical records to evaluate descriptively the treatment patterns and key healthcare resource use among AML patients with or without FLT3 mutation. The current study relies on secondary use of existing data, and there is no intervention involved. Patients who received the first AML treatment after the initial diagnosis, or were classified as relapsed/refractory (R/R), between January 1, 2013 and December 31, 2015 will be randomly selected to be included in this study, and the data from their existing medical records will be extracted. Eligible patients will be grouped based on FLT3 mutation status, intensive chemotherapy (IC) eligibility, and R/R status.
For newly diagnosed patients, the index date will be defined as the initiation date of the first AML treatment following initial diagnosis. For the R/R patients, the index date will be defined as the date of the patient being classified as R/R. The study period will be the period from the index date to last follow-up date or death, whichever comes earlier. The endpoint measurements of this study are treatment patterns and key AML-related healthcare resources used during the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IC eligible AML patients with FLT3 mutation | – | Other: Treatment patterns among AML patients, Other: AML-related healthcare resourcesNewly diagnosed AML patients |
| IC ineligible patients with FLT3 mutation | – | Other: Treatment patterns among AML patients, Other: AML-related healthcare resourcesNewly diagnosed AML patients |
| AML patients after R/R with FLT3 mutation | – | Other: Treatment patterns among AML patients, Other: AML-related healthcare resourcesR/R are relapse/refractory patients |
| IC eligible patients without FLT3 mutation | – | Other: Treatment patterns among AML patients, Other: AML-related healthcare resourcesNewly diagnosed AML patients |
| IC ineligible patients without FLT3 mutation | – | Other: Treatment patterns among AML patients, Other: AML-related healthcare resourcesNewly diagnosed AML patients |
| AML patients after R/R without FLT3 mutation | – | Other: Treatment patterns among AML patients, Other: AML-related healthcare resourcesR/R are relapse/refractory patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult AML patients with or without FLT3 mutation under or previously under the care of participating physicians.
Key inclusion criteria (6 listed)
- Confirmed diagnosis of AML but NOT acute promyelocytic leukemia (APL)
- Known FLT3 mutation status
- Under the care of the participating physician during the past 3 years OR from the initial diagnosis of AML
- The medical records related to AML for the patient are available to the physician and can be abstracted for this study
- The medical records contains complete information on treatments and AML-related hospitalization, including admission date, length of stay, and reason of hospitalization
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment patterns among AML patientsThis is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. | Other | AML patients after R/R with FLT3 mutation, AML patients after R/R without FLT3 mutation, IC eligible AML patients with FLT3 mutation, IC eligible patients without FLT3 mutation, IC ineligible patients with FLT3 mutation, IC ineligible patients without FLT3 mutation |
| AML-related healthcare resourcesThis is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015. | Other | AML patients after R/R with FLT3 mutation, AML patients after R/R without FLT3 mutation, IC eligible AML patients with FLT3 mutation, IC eligible patients without FLT3 mutation, IC ineligible patients with FLT3 mutation, IC ineligible patients without FLT3 mutation |
Primary outcome
Treatment patterns assessed by drugs initiated
Time frame: Up to 3 years
Treatment patterns assessed by dosage
Time frame: Up to 3 years
Treatment patterns assessed by duration of treatment
Time frame: Up to 3 years
Treatment patterns assessed by whether remission was achieved.
Time frame: Up to 3 years
Treatment patterns assessed by an event
Time frame: Up to 3 years
Reported death, failure of treatment or relapse of any type
AML-related healthcare resource use assessed by number of hospitalizations and lengths of ICU hospital stay
Time frame: Up to 3 years
AML-related healthcare resource use assessed by number of emergency department (ED) visits
Time frame: Up to 3 years
AML-related healthcare resource use assessed by number of outpatient visits
Time frame: Up to 3 years
AML-related healthcare resource use assessed by number of blood transfusions
Time frame: Up to 3 years
AML-related healthcare resource use assessed by number of infections and associated treatments
Time frame: Up to 3 years
AML-related healthcare resource use assessed by number of lab tests
Time frame: Up to 3 years
Lab tests include bone marrow biopsy
AML-related healthcare resource use assessed by number of relevant concomitant medications
Time frame: Up to 3 years
AML-related healthcare resource use assessed by number of diagnostic procedures
Time frame: Up to 3 years
AML-related healthcare resource use assessed by use of mechanical ventilation
Time frame: Up to 3 years
AML-related healthcare resource use assessed by use of parenteral feeding
Time frame: Up to 3 years
AML-related healthcare resource use assessed by length of hospice care
Time frame: Up to 3 years
AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
Time frame: Up to 3 years
AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU)
Time frame: Up to 3 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 5 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Astellas Medical Affairs, Global study director
Astellas Medical Affairs, Global
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 (AML), run by Astellas Pharma Global Development, Inc. at 1 site in United States.
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 1 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 5 Nov 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 United States. 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?
Treatment patterns assessed by drugs initiated (time frame: Up to 3 years). The study lists 18 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 5 Nov 2024.