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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05286528
Collaborator
(none)
1,484
1
14.4
102.9

Study Details

Study Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
1484 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Nov 18, 2020
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. [Baseline to date of death from any cause (Jan 1- 2009-June 30-2020)]

    Overall survival of CML patients treated with tyrosine kinase inhibitors in Hungary

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Budapest Hungary

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05286528
Other Study ID Numbers:
  • B1871064
First Posted:
Mar 18, 2022
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022