An observational study in Chronic Myeloid Leukaemia, sponsored by Pfizer. Completed at 1 site in Hungary. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Pfizer · Observational
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
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 1,484 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
All CML patients treated with any TKI with CML diagnosis based on the International Classification of Diseases - 10th revision (ICD) during the investigated timeframe
Exclusion Criteria:
Bosutinib as prescribed in real world
Imatinib as prescribed in real world
Nilotinib as prescribed in real world
Dasatinib as prescribed in real world
Ponatinib as prescribed in real world
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Data of participants, who received tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) anytime from 01 January 2009 to 30 June 2020, under the terms of the current marketing authorization, inclusion criteria, for treatment of chronic myeloid leukemia (CML), was retrieved from database National Health Insurance Fund (NHIF) of Hungary.
| Milestone | Participants With CML |
|---|---|
| Started | 1484 |
| Completed | 1484 |
| Not completed | 0 |
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.
| Percentage of participants | Participants With CML |
|---|---|
| Overall Survival Rate: All Participants | 77.1 |
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.
| Percentage of participants | Participants With CML |
|---|---|
| Overall Survival Rate: Type of First Line TKI | 77.1 |
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.
| Percentage of participants | Participants With CML |
|---|---|
| Overall Survival Rate: Type of Second Line TKI | 71.5 |
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.
No measurements were reported for this outcome.
Collected over Not applicable as adverse events were not collected for the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With CML | — | — | — |
Analysis set included all participants treated with tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2009 to 30 June 2020.
| Age, Continuous(Years) | Participants With CML |
|---|---|
| Mean | 56.14 ± 17.13 |
| Sex: Female, Male(Participants) | Participants With CML |
|---|---|
| Female | 704 |
| Male | 780 |
| Race and Ethnicity Not Collected(Participants) | Participants With CML |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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