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

NCT ID: NCT05286528

Last Updated: 2023-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1484 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-18

Study Completion Date

2022-01-31

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

Detailed Description

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Conditions

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Chronic Myeloid Leukaemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Bosutinib

Bosutinib as prescribed in real world

Intervention Type DRUG

Imatinib

Imatinib as prescribed in real world

Intervention Type DRUG

Nilotinib

Nilotinib as prescribed in real world

Intervention Type DRUG

Dasatinib

Dasatinib as prescribed in real world

Intervention Type DRUG

Ponatinib

Ponatinib as prescribed in real world

Intervention Type DRUG

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Budapest, , Hungary

Site Status

Countries

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Hungary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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B1871064

Identifier Type: -

Identifier Source: org_study_id

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