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

NCT ID: NCT05363488

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-08

Study Completion Date

2021-10-08

Brief Summary

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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.

Detailed Description

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Conditions

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Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronic Myeloid Leukaemia

Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib

Bosutinib

Intervention Type DRUG

Patients receiving bosutinib treatment

Interventions

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Bosutinib

Patients receiving bosutinib treatment

Intervention Type DRUG

Other Intervention Names

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Bosulif

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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eatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B1871058

To obtain contact information for a study center near you, click here.

Other Identifiers

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BOSISCOT

Identifier Type: OTHER

Identifier Source: secondary_id

B1871058

Identifier Type: -

Identifier Source: org_study_id

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