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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib | Drug | Bosutinib as prescribed in real world | ||
| Imatinib | Drug | Imatinib as prescribed in real world | ||
| Nilotinib | Drug | Nilotinib as prescribed in real world | ||
| Dasatinib | Drug | Dasatinib as prescribed in real world | ||
| Ponatinib | Drug | Ponatinib as prescribed in real world |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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All CML patients treated with any TKI with CML diagnosis based on the International Classification of Diseases - 10th revision (ICD) during the investigated timeframe
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Budapest | Hungary |
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With CML | Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2020 |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis set included all participants treated with tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2009 to 30 June 2020.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With CML | Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis set included all participants initiated with first line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020. | Posted | Number | Percentage of 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) |
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| Primary | 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. | Analysis set included all participants initiated with first line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020. | Posted | Number | Percentage of 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) |
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| Primary | 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. | Analysis set included all participants initiated with second line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020. Here, Overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of 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) |
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| Primary | 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. | NHIF did not provide data for event below 10 participants. Apart from 2 sequences all rest sequences had low yearly participants during the whole studied period (less than 10 participants). Hence data for analysis for Overall Survival rate by sequence was not collected and analyzed for whole population. | Posted | 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) |
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Not applicable as adverse events were not collected for the study
Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not meet, hence adverse events were not collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With CML | Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011. | 0 | 0 | 0 | 0 | 0 | 0 |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Inc. | Pfizer ClinicalTrials.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Jan 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C471992 | bosutinib |
| D000068877 | Imatinib Mesylate |
| C498826 | nilotinib |
| D000069439 | Dasatinib |
| C545373 | ponatinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
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