Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
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.
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 be followed until 5 years from study index date are complete (time between enrollment and 5 year follow-up is the prospective component)
Inclusion Criteria:
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 Criteria:
Discontinuation Criteria:
Washington D.C., District of Columbia 20010, United States
Boynton Beach, Florida 33435, United States
Does Not Exist, New Jersey 08690-3542, United States
Martinsburg, West Virginia 25401, United States
Chalon/Saone Cedex, 71100, France
Frankurt Am Main, 60389, Germany
Mülheim A. D. Ruhr, 45468, Germany
Santiago de Compostela-A Coruña, Spain 15706, Spain
Oviedo - Asturias, 33006, Spain