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NCT Number: NCT06297161

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer New York

New York, 10001, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Bosulif

Drug

chronic myelogenous leukemia patients

Primary outcomes

  1. Incidence of AEs

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

Secondary outcomes

  1. Hematologic response: CHR, not achieved

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

  2. Cytogenetic response: CCyR, PCyR, mCyR, not achieved

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

  3. Molecular response: 'Molecular response (MR) 1', 'MR 2', 'MR3/Major MR(MMR)', 'MR 4.0', 'MR4.5', 'MR5'

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

  4. Relapse

    Time frame: From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 7, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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