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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05363488
Other study ID # B1871058
Secondary ID BOSISCOT
Status Completed
Phase
First received
Last updated
Start date October 8, 2021
Est. completion date October 8, 2021

Study information

Verified date March 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date October 8, 2021
Est. primary completion date October 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Bosutinib
Patients receiving bosutinib treatment

Locations

Country Name City State
United Kingdom eatson West of Scotland Cancer Centre Glasgow

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative response rate in partial and complete haematological response (PHR/CHR) 16 May 2019 through 30 Nov 2019
Primary Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR) 16 May 2019 through 30 Nov 2019
Primary Cumulative response rate for molecular response (MR) outcome 16 May 2019 through 30 Nov 2019
Secondary 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
Secondary 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
Secondary 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
Secondary The proportion of patients converting to AP/BC 16 May 2019 through 30 Nov 2019
Secondary Proportion of patients who permanently discontinued treatment with bosutinib following an AE considered as related to bosutinib 16 May 2019 through 30 Nov 2019
Secondary 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
Secondary Mean dosage prescribed at time of initiation and mean dosage during treatment 16 May 2019 through 30 Nov 2019
Secondary Proportion of patients with an increase or reduction in dose 16 May 2019 through 30 Nov 2019
Secondary Mean and relative dose intensity Defined as result of ratio of dose received over expected dose. 16 May 2019 through 30 Nov 2019
Secondary Proportion of patients who temporarily discontinued treatment 16 May 2019 through 30 Nov 2019
Secondary Proportion of patients who permanently discontinued 16 May 2019 through 30 Nov 2019
Secondary 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
Secondary 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
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