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

Pfizer17 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Myeloid Leukemia

Interventions

BosutinibDRUG

Patients receiving bosutinib treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eatson West of Scotland Cancer Center

Glasgow, United Kingdom

Outcomes

Primary Outcomes

Cumulative response rate in partial and complete haematological response (PHR/CHR)

Time frame: 16 May 2019 through 30 Nov 2019

Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR)

Time frame: 16 May 2019 through 30 Nov 2019

Cumulative response rate for molecular response (MR) outcome

Time frame: 16 May 2019 through 30 Nov 2019

Secondary Outcomes

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

Time frame: 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.

Time frame: From initiation of bosutinib to 1 year, 2 year, and 3 year

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)

Time frame: From initiation of bosutinib treatment to date of death up to 30 Nov 2019

The proportion of patients converting to AP/BC

Time frame: 16 May 2019 through 30 Nov 2019

Data from ClinicalTrials.gov

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