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

Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05363488
• Other study ID #: B1871058
• Secondary ID: BOSISCOT
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Myeloid Leukemia

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

External Links

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