Myeloid LeukemiaNCT05363488
Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
An observational study of Myeloid Leukemia, run by Pfizer at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia
- What is being tested?
- Bosutinib
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CML patients in a single center in Scotland.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 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.
- Conditions
- Myeloid Leukemia
- Being tested
- Bosutinib
- Keywords
- Philadelphia chromosome, Breakpoint Cluster Region/ Abelson (BCR/ABL1), retrospective, observational, chromic myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Philadelphia Chromosome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosutinibDrug
Also called Bosulif
Patients receiving bosutinib treatment
| Study group | Role | What they receive |
|---|---|---|
| Chronic Myeloid Leukaemia | Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib Receives: Drug: Bosutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative response rate in partial and complete haematological response (PHR/CHR)
Measured: 16 May 2019 through 30 Nov 2019
Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR)
Measured: 16 May 2019 through 30 Nov 2019
Cumulative response rate for molecular response (MR) outcome
Measured: 16 May 2019 through 30 Nov 2019
Secondary outcomes (13)
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
Measured: 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.
Measured: 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)
Measured: From initiation of bosutinib treatment to date of death up to 30 Nov 2019
The proportion of patients converting to AP/BC
Measured: 16 May 2019 through 30 Nov 2019
Proportion of patients who permanently discontinued treatment with bosutinib following an AE considered as related to bosutinib
Measured: 16 May 2019 through 30 Nov 2019
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.
Measured: 16 May 2019 through 30 Nov 2019
Mean dosage prescribed at time of initiation and mean dosage during treatment
Measured: 16 May 2019 through 30 Nov 2019
Proportion of patients with an increase or reduction in dose
Measured: 16 May 2019 through 30 Nov 2019
Mean and relative dose intensity
Defined as result of ratio of dose received over expected dose.
Measured: 16 May 2019 through 30 Nov 2019
Proportion of patients who temporarily discontinued treatment
Measured: 16 May 2019 through 30 Nov 2019
Proportion of patients who permanently discontinued
Measured: 16 May 2019 through 30 Nov 2019
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.
Measured: 16 May 2019 through 30 Nov 2019
Describe the reason for selection of bosutinib in second line CML setting
Clinician reason given for selecting Bosutinib therapy
Measured: 16 May 2019 through 30 Nov 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 May 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363488
- Sponsor's protocol ID
- B1871058
- Other IDs
- BOSISCOT
- Status last verified
- May 2026
- First submitted
- 15 Mar 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
- ClinicalTrials.gov ID
- NCT05363488
- Acronym / sponsor ID
- B1871058
- Conditions
- Myeloid Leukemia
- Keywords
- Philadelphia chromosome, Breakpoint Cluster Region/ Abelson (BCR/ABL1), retrospective, observational, chromic myeloid leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Myeloid Leukaemia | – | Drug: BosutinibPatients diagnosed with chronic myeloid leukaemia treated with Bosutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CML patients in a single center in Scotland.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosutinibAlso: BosulifPatients receiving bosutinib treatment | Drug | Chronic Myeloid Leukaemia |
Primary outcome
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
13 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
Time frame: 16 May 2019 through 30 Nov 2019
Progression-free survival
Time frame: From initiation of bosutinib to 1 year, 2 year, and 3 year
Overall survival
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
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
Rate of cross-intolerance between bosutinib and previously prescribed tyrosine kinase inhibitors (TKIs)
Time frame: 16 May 2019 through 30 Nov 2019
Mean dosage prescribed at time of initiation and mean dosage during treatment
Time frame: 16 May 2019 through 30 Nov 2019
Proportion of patients with an increase or reduction in dose
Time frame: 16 May 2019 through 30 Nov 2019
Mean and relative dose intensity
Time frame: 16 May 2019 through 30 Nov 2019
Proportion of patients who temporarily discontinued treatment
Time frame: 16 May 2019 through 30 Nov 2019
Proportion of patients who permanently discontinued
Time frame: 16 May 2019 through 30 Nov 2019
Duration of treatment
Time frame: 16 May 2019 through 30 Nov 2019
Describe the reason for selection of bosutinib in second line CML setting
Time frame: 16 May 2019 through 30 Nov 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloid Leukemia, run by Pfizer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative response rate in partial and complete haematological response (PHR/CHR) (time frame: 16 May 2019 through 30 Nov 2019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.