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Real-World study tracks BOSULIF's safety and effectiveness in CML patients

NCT ID NCT06297161

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is observing 600 people with chronic myeloid leukemia (CML) who are taking BOSULIF as part of their normal treatment in Korea. Researchers will track side effects and how well the drug controls the disease over time. The goal is to see if BOSULIF works safely in everyday clinical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bosulif (bosutinib)
What this could lead to
If successful, this study will confirm that BOSULIF is safe and effective for chronic myeloid leukemia patients in everyday clinical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. Side effects are possible, and the study only includes patients in Korea, which may limit how well findings apply elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic leukemia myelogenous

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pfizer New York

    RECRUITING

    New York, New York, 10001, United States