A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).

NCT06297161 | Recruiting

• 2 other identifiers: B1871065NCT06297161
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Chronic Leukemia Myelogenous

Keywords

Philadelphia chromosome-positive (Ph+)

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs

  From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)

Secondary Outcomes (4)

• 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)

Study Arms (1)

Patients with newly diagnosed CP Ph+ CML

Patients newly-diagnosed with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)

Drug: Bosulif

Interventions

Bosulif DRUG

chronic myelogenous leukemia patients

Patients with newly diagnosed CP Ph+ CML

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New York

New York, New York, 10001, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)