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NCT Number: NCT05488613

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

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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midostaurin

Drug

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

Other names: Rydapt

Primary outcomes

  1. Number of patients initiating midostaurin treatment

    Time frame: throughout the study, approximately 5 years

    Number of patients initiating midostaurin treatment were reported.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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