Chronic Leukemia Myelogenous
Conditions
Keywords
Philadelphia chromosome-positive (Ph+)
Brief summary
The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice. This study is seeking for participants who are: 1. Patients who are being treated\* or will be treated with Bosulif according to it's local product document under routine clinical practice (\*Patients who initiated Bosulif treatment within one year before consent) 2. 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. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective. In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study.
Interventions
DRUGBosulif
chronic myelogenous leukemia patients
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are being treated\* or will be treated with Bosulif according to it's local product document under routine clinical practice (\*Patients who initiated Bosulif treatment within one year before consent) 2. 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
\- Patients to whom bosulif is contraindicated as per the local labeling- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs | From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028) |
Secondary
| Measure | Time frame |
|---|---|
| Hematologic response: CHR, not achieved | From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028) |
| Cytogenetic response: CCyR, PCyR, mCyR, not achieved | From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028) |
| Molecular response: 'Molecular response (MR) 1', 'MR 2', 'MR3/Major MR(MMR)', 'MR 4.0', 'MR4.5', 'MR5' | From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028) |
| Relapse | From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028) |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed