Clinical trial

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

Name
B1871064
Description
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
Trial arms
Trial start
2020-11-18
Estimated PCD
2022-01-31
Trial end
2022-01-31
Status
Completed
Treatment
Bosutinib
Bosutinib as prescribed in real world
Imatinib
Imatinib as prescribed in real world
Nilotinib
Nilotinib as prescribed in real world
Dasatinib
Dasatinib as prescribed in real world
Ponatinib
Ponatinib as prescribed in real world
Size
1484
Primary endpoint
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: 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: 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: 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)
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1484, 'type': 'ACTUAL'}}
Updated at
2023-10-27

1 organization

5 products

1 indication

Organization
Pfizer
Product
Bosutinib
Product
Nilotinib
Product
Ponatinib
Product
Imatinib
Product
Dasatinib