Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01244750
Eligibility Criteria:
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:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01244750
Study Brief:
Protocol Section:
NCT01244750