Bosulif treatment for adults with chronic myeloid leukemia
Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF
This project will try bosulif in adults with Philadelphia chromosome–positive chronic myeloid leukemia in routine care to see if it is safe and works well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06297161 on ClinicalTrials.gov |
What this trial studies
This is an observational, post‑marketing program collecting safety and effectiveness information on bosulif when prescribed in routine clinical practice. Eligible adults are those who are being treated with bosulif or who will begin bosulif treatment according to local product labeling, including patients who started within one year before consent. Data are collected during normal clinic visits with informed consent, and patients contraindicated for bosulif or who refuse use of their data are excluded. The study is sponsored by Pfizer and aims to describe real‑world outcomes rather than change assigned treatment.
Who should consider this trial
Good fit: Adults with Philadelphia chromosome–positive chronic myeloid leukemia who are being treated with or will start bosulif according to local labeling and who can give informed consent are ideal candidates.
Not a fit: Patients who are contraindicated for bosulif, who decline consent for use of their data, or who are not treated at participating sites are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could provide real‑world safety and effectiveness data to help doctors and patients make more informed treatment choices with bosulif.
How similar studies have performed: Previous randomized trials and real‑world reports have shown bosutinib (bosulif) can be effective for Philadelphia chromosome–positive CML, so this study is gathering additional routine‑care safety and effectiveness data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Pfizer New York — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.