This trial is active, not recruiting.

Condition chronic myeloid leukaemia
Treatment bosutinib
Targets BCR-ABL, SRC
Sponsor Pfizer
Collaborator pH Associates
Start date July 2015
End date October 2016
Trial size 1 participant
Trial identifier NCT02546375, B1871052


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib
bosutinib Bosulif
Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)

Primary Outcomes

cumulative response rate (haematological (PHR/CHR), cytogenetic (CCyR/MCyR/PCyR) and molecular (MR3/MR4/MR4.5)
time frame: 1 year

Secondary Outcomes

• Progression-free survival at 1 year
time frame: 1 year
Overall survival at 1 year
time frame: 1 year
The proportion of patients who permanently discontinued bosutinib.
time frame: 1 year
The rate of cross-intolerance between bosutinib and previously prescribed TKIs
time frame: 1 year
Progression-free survival at 2 years
time frame: 2 years
Progression-free survival at 3 years
time frame: 3 years
Overall survival at 2 years
time frame: 2 years
Overall survival at 3 years
time frame: 3 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title A Retrospective Observational Research Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Pfizer.