Acute Myeloid Leukemia (AML)NCT05488613
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
An observational study of Acute Myeloid Leukemia (AML), run by Novartis Pharmaceuticals at 1 site in Finland.
Trial summary
This was a non-interventional, retrospective registry study, utilizing electronic health record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS). Real-world health care resource utilization (HCRU) of AML patients was characterized. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Midostaurin
- How many people
- 81 participants
- Where
- 1 siteFinland
- Study dates
- 24 Sep 2020to 26 Jan 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18 years or older) with Acute Myeloid Lukemia
Who may be able to join
- Patients who are diagnosed with acute myeloid leukemia (ICD-10 C92.0) during 1.1.2016-30.6.2020
- Adult (18 years or older) at the time of first diagnosis
- Health registry data is available and accessible
- Resident in the hospital district HUS at the time of index diagnosis
Who cannot join
- AML patients with no treatment information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) With a Focus on Patients Treated With Rydapt (Midostaurin) in Helsinki and Uusimaa Hospital District
This was a non-interventional, retrospective registry study, utilizing electronic health record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS). Real-world health care resource utilization (HCRU) of AML patients was characterized.
Read the detailed description
Adult patients (18 years or older) with the inclusion diagnosis, AML (ICD-10 C92.0), between 1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion diagnosis) until the end of follow-up (30.6.2020), or death. This study did not involve any contacts to patients.
The study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to 1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Midostaurin
- Keywords
- Acute myeloid leukemia,, midostaurin,, healthcare resource utilization
- 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.
MidostaurinDrug
Also called Rydapt
Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Midostaurin | Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. Receives: Drug: Midostaurin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients initiating midostaurin treatment
Number of patients initiating midostaurin treatment were reported.
Measured: throughout the study, approximately 5 years
Secondary outcomes (7)
Number of patients who received Midostaurin at induction and consolidation phases
Number of patients who received Midostaurin at induction and consolidation phases were reported.
Measured: throughout the study, approximately 5 years
Duration of Midostaurin at induction and consolidation phase
Duration of Midostaurin at induction and consolidation phase were reported.
Measured: throughout the study, approximately 5 years
Median average dose intensity in midostaurin treatment in induction and consolidation phase
Median average dose intensity in midostaurin treatment were reported.
Measured: throughout the study, approximately 5 years
Most frequent comorbidities at the time of AML diagnosis
Most frequent comorbidities at the time of AML diagnosis were reported.
Measured: throughout the study, approximately 5 years
Number of patients at the time of diagnosis (All treated AML patients)
Number of patients at the time of diagnosis (All treated AML patients) were reported.
Measured: throughout the study, approximately 5 years
Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions)
Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions) were reported.
Measured: throughout the study, approximately 5 years
Mean HCRU and related costs in different disease stages
Estimate HCRU and related costs in different disease stages were reported.
Measured: throughout the study, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start24 Sep 2020
- Primary completion26 Jan 2021
- Study completion26 Jan 2021
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 Novartis PharmaceuticalsThe 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488613
- Sponsor's protocol ID
- CPKC412AFI02
- Status last verified
- Nov 2022
- First submitted
- 3 Aug 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) With a Focus on Patients Treated With Rydapt (Midostaurin) in Helsinki and Uusimaa Hospital District
- ClinicalTrials.gov ID
- NCT05488613
- Acronym / sponsor ID
- CPKC412AFI02
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute myeloid leukemia,, midostaurin,, healthcare resource utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 4 Aug 2022 (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 was a non-interventional, retrospective registry study, utilizing electronic health record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS). Real-world health care resource utilization (HCRU) of AML patients was characterized.
Detailed description
Adult patients (18 years or older) with the inclusion diagnosis, AML (ICD-10 C92.0), between 1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion diagnosis) until the end of follow-up (30.6.2020), or death. This study did not involve any contacts to patients.
The study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to 1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midostaurin | – | Drug: MidostaurinMidostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years or older) with Acute Myeloid Lukemia
Key inclusion criteria (4 listed)
- Patients who are diagnosed with acute myeloid leukemia (ICD-10 C92.0) during 1.1.2016-30.6.2020
- Adult (18 years or older) at the time of first diagnosis
- Health registry data is available and accessible
- Resident in the hospital district HUS at the time of index diagnosis
Key exclusion criteria (1 listed)
- AML patients with no treatment information
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 |
|---|---|---|
| MidostaurinAlso: RydaptMidostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. | Drug | Midostaurin |
Primary outcome
Number of patients initiating midostaurin treatment
Time frame: throughout the study, approximately 5 years
Number of patients initiating midostaurin treatment were reported.
7 secondary outcomes
Number of patients who received Midostaurin at induction and consolidation phases
Time frame: throughout the study, approximately 5 years
Duration of Midostaurin at induction and consolidation phase
Time frame: throughout the study, approximately 5 years
Median average dose intensity in midostaurin treatment in induction and consolidation phase
Time frame: throughout the study, approximately 5 years
Most frequent comorbidities at the time of AML diagnosis
Time frame: throughout the study, approximately 5 years
Number of patients at the time of diagnosis (All treated AML patients)
Time frame: throughout the study, approximately 5 years
Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions)
Time frame: throughout the study, approximately 5 years
Mean HCRU and related costs in different disease stages
Time frame: throughout the study, approximately 5 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 8 Nov 2022.
- Results for CPKC412AFI02 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Novartis Pharmaceuticals at 1 site in Finland.
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 4 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 8 Nov 2022. 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 Finland. 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?
Number of patients initiating midostaurin treatment (time frame: throughout the study, approximately 5 years). 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 8 Nov 2022.