Review of Chronic Myelogenous Leukemia Patients Treated with Imatinib
Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
This study looks at how well imatinib works for people with Chronic Myelogenous Leukemia in everyday settings by reviewing their treatment experiences and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | imatinib, dasatinib, nilotinib |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT00816114 on ClinicalTrials.gov |
What this trial studies
This study involves a comprehensive chart review of Chronic Myelogenous Leukemia (CML) patients who have been treated with tyrosine kinase inhibitors like imatinib outside of clinical trials. Researchers will collect demographic data, treatment history, laboratory values, and information on treatment toxicity and pregnancy outcomes. The goal is to better understand the long-term effects and management of CML in a real-world setting, as these patients may differ significantly from those in clinical trials. The study aims to gather data from over 300 patients who have sought second opinions at MD Anderson Cancer Center.
Who should consider this trial
Good fit: Ideal candidates include patients with any phase of CML who have received treatment with FDA-approved tyrosine kinase inhibitors and have had at least one visit at MD Anderson.
Not a fit: Patients who have not received treatment with tyrosine kinase inhibitors or have not visited MD Anderson will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management and outcomes of CML patients treated with tyrosine kinase inhibitors.
How similar studies have performed: While there have been successful studies on CML treatments, this observational approach focusing on real-world data from patients outside clinical trials is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients with CML in any phase of the disease (chronic, accelerated or blast phase) that has received treatment with any FDA-approved tyrosine kinase inhibitor (eg, imatinib, dasatinib, nilotinib) not on an MDACC clinical trial regardless of prior treatment history that has had at least one clinic visit at MDACC will be eligible. Exclusion Criteria: N/A
Where this trial is running
Houston, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Koji Sasaki, M.D. — M.D. Anderson Cancer Center
- Study coordinator: Koji Sasaki, M.D.
- Email: ksasaki1@mdanderson.org
- Phone: (713) 745-2882
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.