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

Acute Myeloid Leukemia (AML) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488613
• Other study ID #: CPKC412AFI02
• Status: Completed
• Start date: September 24, 2020
• Est. completion date: January 26, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Midostaurin
Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.

Locations

Country	Name	City	State
Finland	Novartis Investigative Site	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients initiating midostaurin treatment	Number of patients initiating midostaurin treatment were reported.	throughout the study, approximately 5 years
Secondary	Number of patients who received Midostaurin at induction and consolidation phases	Number of patients who received Midostaurin at induction and consolidation phases were reported.	throughout the study, approximately 5 years
Secondary	Duration of Midostaurin at induction and consolidation phase	Duration of Midostaurin at induction and consolidation phase were reported.	throughout the study, approximately 5 years
Secondary	Median average dose intensity in midostaurin treatment in induction and consolidation phase	Median average dose intensity in midostaurin treatment were reported.	throughout the study, approximately 5 years
Secondary	Most frequent comorbidities at the time of AML diagnosis	Most frequent comorbidities at the time of AML diagnosis were reported.	throughout the study, approximately 5 years
Secondary	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.	throughout the study, approximately 5 years
Secondary	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.	throughout the study, approximately 5 years
Secondary	Mean HCRU and related costs in different disease stages	Estimate HCRU and related costs in different disease stages were reported.	throughout the study, approximately 5 years

External Links

•   Results for CPKC412AFI02 from the Novartis Clinical Trials Website