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
2 other identifiers
observational
17
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2021
CompletedFirst Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedApril 3, 2023
March 1, 2023
Same day
March 15, 2022
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (13)
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
16 May 2019 through 30 Nov 2019
Progression-free survival
From initiation of bosutinib to 1 year, 2 year, and 3 year
Overall survival
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
- +8 more secondary outcomes
Study Arms (1)
Chronic Myeloid Leukaemia
Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib
Interventions
Eligibility Criteria
CML patients in a single center in Scotland.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
eatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
May 6, 2022
Study Start
October 8, 2021
Primary Completion
October 8, 2021
Study Completion
October 8, 2021
Last Updated
April 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
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.