Clinical trial NCT05363488: Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
Official title: A Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloid Leukemia
Keywords: Philadelphia chromosome
Breakpoint Cluster Region/ Abelson (BCR/ABL1)
retrospective
observational
chromic myeloid leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CML patients in a single center in Scotland.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative response rate in partial and complete haematological response (PHR/CHR)
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR)
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Cumulative response rate for molecular response (MR) outcome
timeFrame: 16 May 2019 through 30 Nov 2019
Secondary outcomes:
measure: 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
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Progression-free survival
timeFrame: From initiation of bosutinib to 1 year, 2 year, and 3 year
measure: Overall survival
timeFrame: From initiation of bosutinib treatment to date of death up to 30 Nov 2019
measure: The proportion of patients converting to AP/BC
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Proportion of patients who permanently discontinued treatment with bosutinib following an AE considered as related to bosutinib
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Rate of cross-intolerance between bosutinib and previously prescribed tyrosine kinase inhibitors (TKIs)
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Mean dosage prescribed at time of initiation and mean dosage during treatment
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Proportion of patients with an increase or reduction in dose
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Mean and relative dose intensity
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Proportion of patients who temporarily discontinued treatment
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Proportion of patients who permanently discontinued
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Duration of treatment
timeFrame: 16 May 2019 through 30 Nov 2019
measure: Describe the reason for selection of bosutinib in second line CML setting
timeFrame: 16 May 2019 through November 2019
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: eatson West of Scotland Cancer Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: