Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland

Study Overview
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Brief Summary
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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.

Official Title
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A Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland

Conditions
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Myeloid Leukemia

Intervention / Treatment
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* Drug: Bosutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation. Patients prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27 March 2013) by the EMA OR via the compassionate use programme prior to marketing authorization. Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: Patients prescribed bosutinib as part of an interventional clinical trial programme. Patients initiated on bosutinib less than 3 months prior to data collection taking place. Patients prescribed bosutinib as exclusively post-allograft therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Myeloid Leukaemia<br>Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib | Drug: Bosutinib<br>* Patients receiving bosutinib treatment<br>* Other names: Bosulif;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 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 November 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Philadelphia chromosome, Breakpoint Cluster Region/ Abelson (BCR/ABL1), retrospective, observational, chromic myeloid leukemia