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A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands

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NCT02546375

Last updated on October 13, 2019
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Study Location
Royal Liverpool Hospital
Liverpool, Merseyside, L7 8XP United Kingdom
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myeloid Leukaemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.

- Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal
clinical practice since it received marketing authorisation (27th March 2013) by the
EMA11 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prescribed bosutinib as part of an interventional clinical trial programme.

- Initiated on bosutinib less than 3 months prior to data collection taking place.

NCT02546375
Pfizer
Completed
A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands

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Descriptive Information
Brief TitleA Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
Official TitleA RETROSPECTIVE OBSERVATIONAL RESEARCH STUDY TO DESCRIBE THE REAL WORLD USE OF BOSUTINIB IN THE UK AND NETHERLANDS
Brief SummaryThe purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationCML out-patient clinics
ConditionChronic Myeloid Leukaemia
InterventionDrug: Bosutinib
Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)
Other Name: Bosulif
Study Groups/CohortsChronic Myeloid Leukaemia
Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib
Intervention: Drug: Bosutinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: December 15, 2017)		87
Original Estimated Enrollment
 (submitted: September 8, 2015)		100
Actual Study Completion DateJanuary 16, 2017
Actual Primary Completion DateJanuary 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of Ph+ CML aged ?18 years at bosutinib initiation.
  • Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27th March 2013) by the EMA11 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:

  • Prescribed bosutinib as part of an interventional clinical trial programme.
  • Initiated on bosutinib less than 3 months prior to data collection taking place.
Sex/GenderNot Provided
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited Kingdom
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02546375
Other Study ID NumbersB1871052
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorspH Associates
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2019

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