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

NCT05488613 | Completed

• 1 other identifier: CPKC412AFI02
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute myeloid leukemia,; midostaurin,; healthcare resource utilization

Outcome Measures

Primary Outcomes (1)

• Number of patients initiating midostaurin treatment

  Number of patients initiating midostaurin treatment were reported.

  throughout the study, approximately 5 years

Secondary Outcomes (7)

• Number of patients who received Midostaurin at induction and consolidation phases

  throughout the study, approximately 5 years

• Duration of Midostaurin at induction and consolidation phase

  throughout the study, approximately 5 years

• Median average dose intensity in midostaurin treatment in induction and consolidation phase

  throughout the study, approximately 5 years

• Most frequent comorbidities at the time of AML diagnosis

  throughout the study, approximately 5 years

• Number of patients at the time of diagnosis (All treated AML patients)

  throughout the study, approximately 5 years

Study Arms (1)

Midostaurin

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

Drug: Midostaurin

Interventions

Midostaurin DRUG

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

Also known as: Rydapt

Midostaurin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- AML patients with no treatment information

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Helsinki, Finland

Location

Related Links

• Results for CPKC412AFI02 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

midostaurin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 4, 2022
• Study Start: September 24, 2020
• Primary Completion: January 26, 2021
• Study Completion: January 26, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)