Clinical trial NCT06297161: A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).
Official title: Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Leukemia Myelogenous
Keywords: Philadelphia chromosome-positive (Ph+)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Newly-diagnosed 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 who are administrated Bosulif according to the approval label in Korea.

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:

* Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.
* willing to take part in the study after being informed about 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.


Eligibility criteria: Inclusion Criteria:

* Adult Patients newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or CP, AP, BP Ph+ CML with resistance or intolerance to prior therapy
* 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

Primary outcomes:
measure: Incidence of AEs
timeFrame: From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
Secondary outcomes:
measure: Hematologic response: CHR, not achieved
timeFrame: From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
measure: Cytogenetic response: CCyR, PCyR, mCyR, not achieved
timeFrame: From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
measure: Moleccular response: EMR, MMR, MR4.0, MR4.5, not achieved
timeFrame: From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
measure: Relapse after Bosulif response
timeFrame: From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: