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Clinical Trial NCT06297161 for Chronic Leukemia Myelogenous is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML). 600

Active, not recruiting
Clinical Trial NCT06297161 is an observational study for Chronic Leukemia Myelogenous that is active, not recruiting. It started on January 20, 2025 with plans to enroll 600 participants. Led by Pfizer, it is expected to complete by June 1, 2028. The latest data from ClinicalTrials.gov was last updated on December 1, 2025.
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:

  • 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 a...
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Official Title

Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF

Conditions
Chronic Leukemia Myelogenous
Other Study IDs
  • B1871065
  • NCT06297161 (Registry Identifier) (ClinicalTrials.gov)
NCT ID Number
NCT06297161
Start Date (Actual)
2025-01-20
Last Update Posted
2025-12-01
Completion Date (Estimated)
2028-06-01
Enrollment (Estimated)
600
Study Type
Observational
Status
Active, not recruiting
Keywords
Philadelphia chromosome-positive (Ph+)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Patients with newly diagnosed CP Ph+ CML
Patients newly-diagnosed with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
Bosulif
chronic myelogenous leukemia patients
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
All
  • 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.

- 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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No contact data.
1 Study Locations in 1 Countries

New York

Pfizer New York, New York, New York, 10001, United States