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Completed

NCT Number: NCT05363488

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

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.

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Key information

Conditions

Myeloid Leukemia Chromosome Aberrations Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Philadelphia Chromosome Translocation, Genetic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eatson West of Scotland Cancer Center

Glasgow, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosutinib

Drug

Patients receiving bosutinib treatment

Other names: Bosulif

Primary outcomes

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

    Time frame: 16 May 2019 through 30 Nov 2019

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

    Time frame: 16 May 2019 through 30 Nov 2019

  3. Cumulative response rate for molecular response (MR) outcome

    Time frame: 16 May 2019 through 30 Nov 2019

Secondary outcomes

  1. 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

    Time frame: 16 May 2019 through 30 Nov 2019

    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

  2. Progression-free survival

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

    Progression will be defined as change from chronic to accelerated phase or to blast crisis.

  3. Overall survival

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

    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)

  4. The proportion of patients converting to AP/BC

    Time frame: 16 May 2019 through 30 Nov 2019

  5. Proportion of patients who permanently discontinued treatment with bosutinib following an AE considered as related to bosutinib

    Time frame: 16 May 2019 through 30 Nov 2019

  6. Rate of cross-intolerance between bosutinib and previously prescribed tyrosine kinase inhibitors (TKIs)

    Time frame: 16 May 2019 through 30 Nov 2019

    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.

  7. Mean dosage prescribed at time of initiation and mean dosage during treatment

    Time frame: 16 May 2019 through 30 Nov 2019

  8. Proportion of patients with an increase or reduction in dose

    Time frame: 16 May 2019 through 30 Nov 2019

  9. Mean and relative dose intensity

    Time frame: 16 May 2019 through 30 Nov 2019

    Defined as result of ratio of dose received over expected dose.

  10. Proportion of patients who temporarily discontinued treatment

    Time frame: 16 May 2019 through 30 Nov 2019

  11. Proportion of patients who permanently discontinued

    Time frame: 16 May 2019 through 30 Nov 2019

  12. Duration of treatment

    Time frame: 16 May 2019 through 30 Nov 2019

    Duration of initiation up to end of treatment will be calculated for all causes of discontinuation combined and according to cause for discontinuation.

  13. Describe the reason for selection of bosutinib in second line CML setting

    Time frame: 16 May 2019 through 30 Nov 2019

    Clinician reason given for selecting Bosutinib therapy

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 6, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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