B1871065 = Bosulif in Adult Patients With CML [South Korea]
Study title
A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia (CML).
Scientific title
Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF
Type of study
Observational
Phase
Current status
Recruiting
Other trial ID
ClinicalTrials.gov NCT06297161
What is the purpose of the study
The purpose of this study is to assess the safety and effectiveness of Bosulif (bosutinib) in routine clinical practice.
What will happen during the study
All participants in this study will be treated with Bosulif under routine clinical practice in Korea.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 20 years and older.
- have been newly diagnosed with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy
- are being treated or will be treated with Bosulif according to it’s locally approved label under routine clinical practice. Patients who are being treated must have started treatment with Bosulif within one year before giving consent to particiating in this study.
- have given personally signed and dated informed consent prior to study enrollment.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- meet any of the contraindications to the administration of Bosulif according to the locally approved label.
- do not agree that Pfizer and companies working with Pfizer use his/her information.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US register ClinicalTrials.gov, This is a database provided by the U. S. National Institutes of Health.
Study sponsor
Pfizer
Scientific lead / contact
Principal investigator
Study centers / principal investigators
South Korea
Korean health care centers where Bosulif is prescribed to treat CML