Clinical trial NCT05488613: Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute myeloid leukemia,
midostaurin,
healthcare resource utilization
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18 years or older) with Acute Myeloid Lukemia

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- AML patients with no treatment information

Primary outcomes:
measure: Number of patients initiating midostaurin treatment
timeFrame: throughout the study, approximately 5 years
Secondary outcomes:
measure: Number of patients who received Midostaurin at induction and consolidation phases
timeFrame: throughout the study, approximately 5 years
measure: Duration of Midostaurin at induction and consolidation phase
timeFrame: throughout the study, approximately 5 years
measure: Median average dose intensity in midostaurin treatment in induction and consolidation phase
timeFrame: throughout the study, approximately 5 years
measure: Most frequent comorbidities at the time of AML diagnosis
timeFrame: throughout the study, approximately 5 years
measure: Number of patients at the time of diagnosis (All treated AML patients)
timeFrame: throughout the study, approximately 5 years
measure: Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions)
timeFrame: throughout the study, approximately 5 years
measure: Mean HCRU and related costs in different disease stages
timeFrame: throughout the study, approximately 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: