CompletedNot Applicable

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

United Kingdom17 participantsStarted 2019-05-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 16 May 2019 through 30 Nov 2019

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

Timeframe: 16 May 2019 through 30 Nov 2019

Cumulative response rate for molecular response (MR) outcome

Timeframe: 16 May 2019 through 30 Nov 2019

Trial details

NCT IDNCT05363488

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-11-01

View on ClinicalTrials.gov More Myeloid Leukemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 16 May 2019 through 30 Nov 2019

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

Timeframe: 16 May 2019 through 30 Nov 2019

Cumulative response rate for molecular response (MR) outcome

Timeframe: 16 May 2019 through 30 Nov 2019