Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database

Completed

• Conditions: Chronic Myeloid Leukaemia

• Registration Number: NCT05286528
• Lead Sponsor: Pfizer

Brief Summary

The objectives of this study are to describe patient demographics, clinical and disease characteristics and treatment patterns of Chronic Lymphoid Leukaemia (CML) in Hungary.

The primary endpoint of this study is the overall survival of CML patients treated with tyrosine kinase inhibitors in Hungary. The Overall Survival (OS) of all enrolled patients, OS by sequence pattern and by the number of treatment lines will be analyzed.

Secondary objectives are description of the treatment length in 1st and later lines, incidence and prevalence of CML, the patient demographics (as age, gender, comorbidities), average number of patients' comorbidities, most frequent comorbidities and patient number with comorbidities at baseline and at different treatment lines by investigated Thyrosine Kinase Inhibitor (TKI), distribution of the investigated TKI therapies by treatment lines

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Results First Submitted: 2023-01-04
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Results First Posted: 2023-10-27
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1484

Inclusion Criteria

• Female and male patients diagnosed with chronic myeloid leukemia
• Patients receiving tyrosine kinase inhibitor therapy under the terms of the current marketing authorization

Exclusion Criteria

• Patients receiving TKI for non-CML diagnoses

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival Rate: Type of Second Line TKI	5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)	Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Overall Survival Rate: All Participants	5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)	Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Overall Survival Rate: Per Sequence of Treatment	5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)	Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Overall Survival Rate: Type of First Line TKI	5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)	Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.

Trial Locations

Locations (1)

Pfizer; 🇭🇺 Budapest, Hungary