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

November 7, 2022 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (18 years or older) with Acute Myeloid Lukemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Midostaurin
Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.
Drug: Midostaurin
Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.
Other Names:
  • Rydapt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients initiating midostaurin treatment
Time Frame: throughout the study, approximately 5 years
Number of patients initiating midostaurin treatment were reported.
throughout the study, approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who received Midostaurin at induction and consolidation phases
Time Frame: throughout the study, approximately 5 years
Number of patients who received Midostaurin at induction and consolidation phases were reported.
throughout the study, approximately 5 years
Duration of Midostaurin at induction and consolidation phase
Time Frame: throughout the study, approximately 5 years
Duration of Midostaurin at induction and consolidation phase were reported.
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
Median average dose intensity in midostaurin treatment were reported.
throughout the study, approximately 5 years
Most frequent comorbidities at the time of AML diagnosis
Time Frame: throughout the study, approximately 5 years
Most frequent comorbidities at the time of AML diagnosis were reported.
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 patients at the time of diagnosis (All treated AML patients) were reported.
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
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
Mean HCRU and related costs in different disease stages
Time Frame: throughout the study, approximately 5 years
Estimate HCRU and related costs in different disease stages were reported.
throughout the study, approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

January 26, 2021

Study Completion (Actual)

January 26, 2021

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPKC412AFI02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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