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:

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.

Study Overview

• Status: 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

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Recruiting
      • Pfizer New York

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:

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

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: '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)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

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): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Philadelphia chromosome-positive (Ph+)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; bosutinib
• Other Study ID Numbers: B1871065; NCT06297161 (Registry Identifier: ClinicalTrials.gov)

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No