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

Study Overview
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Brief Summary
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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

Official Title
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Retrospective, Non-interventional Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database

Conditions
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Chronic Myeloid Leukaemia

Intervention / Treatment
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* Drug: Bosutinib
* Drug: Imatinib
* Drug: Nilotinib
* Drug: Dasatinib
* Drug: Ponatinib


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bosutinib|Bosutinib as prescribed in real world|
|Drug: Imatinib|Imatinib as prescribed in real world|
|Drug: Nilotinib|Nilotinib as prescribed in real world|
|Drug: Dasatinib|Dasatinib as prescribed in real world|
|Drug: Ponatinib|Ponatinib as prescribed in real world|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rate: All Participants | 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. | 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: Type of First Line TKI | 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. | 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: Type of Second Line TKI | 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. | 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: Per Sequence of Treatment | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tyrosine kinase inhibitor (TKI)