Clinical trial · Observational
A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).
Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Leukemia Myelogenous | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bosulif | Drug | Bosutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients with newly diagnosed CP Ph+ CML
- description
- Patients newly-diagnosed with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
- interventionNames
- Drug: Bosulif
Primary outcomes (1)
- measure
- Incidence of AEs
- timeFrame
- From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
Secondary outcomes (4)
- measure
- Hematologic response: CHR, not achieved
- timeFrame
- From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
- measure
- Cytogenetic response: CCyR, PCyR, mCyR, not achieved
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available