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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Leukemia Myelogenous
• Intervention / Treatment: Drug: Bosulif

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with newly diagnosed CP Ph+ CML; Patients newly-diagnosed with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)	Drug: Bosulif; chronic myelogenous leukemia patients

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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: EMR, MMR, MR4.0, MR4.5, not achieved	From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)
Relapse after Bosulif response	From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Philadelphia chromosome-positive (Ph+)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Bosutinib
• Other Study ID Numbers: B1871065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.