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

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

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.

Study Overview

• Status: Completed
• Conditions: Myeloid Leukemia
• Intervention / Treatment: Drug: Bosutinib

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Eatson West of Scotland Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

CML patients in a single center in Scotland.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Myeloid Leukaemia; Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib	Drug: Bosutinib; Patients receiving bosutinib treatment; Other Names: Bosulif

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
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
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: observational; retrospective; Philadelphia chromosome; Breakpoint Cluster Region/ Abelson (BCR/ABL1); chromic myeloid leukemia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Translocation, Genetic; Chromosome Aberrations; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Philadelphia Chromosome; bosutinib
• Other Study ID Numbers: B1871058; BOSISCOT (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.