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Clinical trial

A RETROSPECTIVE OBSERVATIONAL RESEARCH STUDY TO DESCRIBE THE REAL WORLD USE OF BOSUTINIB IN THE UK AND NETHERLANDS

ID
Name
B1871052
Description
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
Trial arms
Trial start
2015-07-15
Estimated PCD
2017-01-16
Trial end
2017-01-16
Status
Completed
Treatment
Bosutinib
Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)
Arms:
Chronic Myeloid Leukaemia
Other names:
Bosulif
Size
87
Primary endpoint
Percentage of Participants With Cumulative Complete Haematological Response (CHR)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Partial Haematological Response (PHR)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5)
Baseline up to 5.5 years
Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0)
Baseline up to 5.5 years
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 87, 'type': 'ACTUAL'}}
Updated at
2023-10-03

1 organization

1 product

1 indication

Organization
Pfizer
Product
Bosutinib
Indication
Chronic Myeloid Leukaemia