Status:
COMPLETED
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
Detailed Description
Time Perspective : Most patients are expected to be a mix of retrospective and prospective data collection. Patients can be enrolled after their study index date (retrospective component) and have to ...
Eligibility Criteria
Inclusion
- Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below
- 18 years or older at time of of CP-CML diagnosis
- a) Imatinib Cohorts
- Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010.Patients fitting this criterion are defined as retrospective Imatinib patients
- Patients who started their first-line Imatinib treatment on or after October 1, 2010
- b) Dasatinib Cohort
- Patients who started their first-line Dasatinib treatment after the drug was approved in this indication
- c) Nilotinib Cohort
- Patients who started their first-line Nilotinib treatment after the drug was approved in this indication
- Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site for data entry into the study Electronic Case Report Form (eCRF)
- Receiving treatment at medical practice (eg. community-based, office-based, hospital-based, academic setting, oncology center)
Exclusion
- Patients who are participating in an interventional trial which may influence the management of their CML disease will be excluded
- Discontinuation Criteria:
- Enrolled patients who join an interventional trial which may influence the management of their CML disease will be excluded at the time of entry into the interventional trial
Key Trial Info
Start Date :
December 2 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
1494 Patients enrolled
Trial Details
Trial ID
NCT01244750
Start Date
December 2 2010
End Date
January 8 2020
Last Update
June 30 2022
Active Locations (214)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
2
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States, 85016
3
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States, 86336
4
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85704