Clinical trial NCT02546375: A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
Official title: A RETROSPECTIVE OBSERVATIONAL RESEARCH STUDY TO DESCRIBE THE REAL WORLD USE OF BOSUTINIB IN THE UK AND NETHERLANDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukaemia
Keywords: Bosutinib
chronic myeloid leukaemia
retrospective
observational
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: pH Associates
First posted: 2015-09-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CML out-patient clinics

Brief summary: The 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


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.

Primary outcomes:
measure: Percentage of Participants With Cumulative Complete Haematological Response (CHR)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Partial Haematological Response (PHR)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0)
timeFrame: Baseline up to 5.5 years
Secondary outcomes:
measure: Percentage of Participants With Treatment Related Adverse Events (AEs)
timeFrame: Baseline up to 5.5 years
measure: Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3
timeFrame: Baseline up to 5.5 years
measure: Progression-free Survival (PFS)
timeFrame: Year 1, 2, 3
measure: Overall Survival (OS)
timeFrame: From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3
measure: Percentage of Participants With Disease Progression
timeFrame: Year 1, 2, 3
measure: Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy
timeFrame: Baseline up to 5.5 years
measure: Cross-Intolerance Between Bosutinib and Previous Therapy
timeFrame: Baseline up to 5.5 years
measure: Mean Dose of Bosutinib at Initiation of Treatment
timeFrame: Baseline up to 5.5 years
measure: Relative Bosutinib Dose Intensity
timeFrame: Baseline up to 5.5 years
measure: Duration of Bosutinib Therapy
timeFrame: Baseline up to 5.5 years
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Hospital
state: Merseyside
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: