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| ID | Type | Description | Link |
|---|---|---|---|
| BOSISCOT | Other Identifier | Alias Study Number |
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This study will describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia (CML) used in a real world clinical practice setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Myeloid Leukaemia | Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib | Drug | Patients receiving bosutinib treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative response rate in partial and complete haematological response (PHR/CHR) | 16 May 2019 through 30 Nov 2019 | |
| Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR) | 16 May 2019 through 30 Nov 2019 | |
| Cumulative response rate for molecular response (MR) outcome | 16 May 2019 through 30 Nov 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Philadelphia chromosome positive (Ph+) CML in chronic phase (CP), accelerated phase (AP) or blast crisis (BC) presenting with adverse events (AEs) considered related to bosutinib | AEs related to Bosutinib defined by investigator and by will be described overall (all grades of severity combined, all types of events combined) and according to grade (1,2,3 and 4 and grade 3 / 4) and by type of event |
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Inclusion Criteria:
Exclusion Criteria:
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CML patients in a single center in Scotland.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eatson West of Scotland Cancer Center | Glasgow | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D010677 | Philadelphia Chromosome |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C471992 | bosutinib |
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| 16 May 2019 through 30 Nov 2019 |
| Progression-free survival | Progression will be defined as change from chronic to accelerated phase or to blast crisis. | From initiation of bosutinib to 1 year, 2 year, and 3 year |
| Overall survival | Overall survival will be defined as the duration between initiation of bosutinib and date of death (all causes combined) (Kaplan Meier method)death (all causes combined) (Kaplan Meier method) | From initiation of bosutinib treatment to date of death up to 30 Nov 2019 |
| The proportion of patients converting to AP/BC | 16 May 2019 through 30 Nov 2019 |
| Proportion of patients who permanently discontinued treatment with bosutinib following an AE considered as related to bosutinib | 16 May 2019 through 30 Nov 2019 |
| Rate of cross-intolerance between bosutinib and previously prescribed tyrosine kinase inhibitors (TKIs) | Cross-intolerance will be defined as the number of patients who permanently discontinued bosutinib because of an AE which resulted in discontinuation of a previous treatment (imatinib, dasatinib, nilotinib). Cross-intolerance will be estimated for all AEs, but also by type of AEs. | 16 May 2019 through 30 Nov 2019 |
| Mean dosage prescribed at time of initiation and mean dosage during treatment | 16 May 2019 through 30 Nov 2019 |
| Proportion of patients with an increase or reduction in dose | 16 May 2019 through 30 Nov 2019 |
| Mean and relative dose intensity | Defined as result of ratio of dose received over expected dose. | 16 May 2019 through 30 Nov 2019 |
| Proportion of patients who temporarily discontinued treatment | 16 May 2019 through 30 Nov 2019 |
| Proportion of patients who permanently discontinued | 16 May 2019 through 30 Nov 2019 |
| Duration of treatment | Duration of initiation up to end of treatment will be calculated for all causes of discontinuation combined and according to cause for discontinuation. | 16 May 2019 through 30 Nov 2019 |
| Describe the reason for selection of bosutinib in second line CML setting | Clinician reason given for selecting Bosutinib therapy | 16 May 2019 through 30 Nov 2019 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D014178 | Translocation, Genetic |
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |