Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)

Completed

• Conditions: Acute Myeloid Leukemia (AML)
• Interventions: Drug: Midostaurin

• Registration Number: NCT05488613
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study Start: 2020-09-24
• Primary Completion: 2021-01-26
• Study Completion: 2021-01-26
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Midostaurin	Midostaurin	Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.

Primary Outcome Measures

Name	Time	Method
Number of patients initiating midostaurin treatment	throughout the study, approximately 5 years	Number of patients initiating midostaurin treatment were reported.

Secondary Outcome Measures

Name	Time	Method
Mean HCRU and related costs in different disease stages	throughout the study, approximately 5 years	Estimate HCRU and related costs in different disease stages were reported.
Number of patients at the time of diagnosis (All treated AML patients)	throughout the study, approximately 5 years	Number of patients at the time of diagnosis (All treated AML patients) were reported.
Median average dose intensity in midostaurin treatment in induction and consolidation phase	throughout the study, approximately 5 years	Median average dose intensity in midostaurin treatment were reported.
Most frequent comorbidities at the time of AML diagnosis	throughout the study, approximately 5 years	Most frequent comorbidities at the time of AML diagnosis were reported.
Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions)	throughout the study, approximately 5 years	Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions) were reported.
Number of patients who received Midostaurin at induction and consolidation phases	throughout the study, approximately 5 years	Number of patients who received Midostaurin at induction and consolidation phases were reported.
Duration of Midostaurin at induction and consolidation phase	throughout the study, approximately 5 years	Duration of Midostaurin at induction and consolidation phase were reported.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇮 Helsinki, Finland