This is an observational registry to further characterize the safety profile of patients with chronic myeloid leukemia in the chronic phase (CP-CML), accelerated phase (AP-CML), blast phase (BP-CML), or Ph+ALL treated with Iclusig (ponatinib) in routine clinical practice in the US. The registry is focused on analysis of vascular occlusive events.
The registry is being conducted in an effort to better understand rates, risk factors, and outcomes associated with vascular occlusive events in patients treated with Iclusig (ponatinib) in real world settings. This registry study will collect information about patient demographics, leukemia diagnosis, previous anti-cancer treatments, history of cardiovascular disease, risk factors for vascular complications, and concurrent medications (including antiplatelet and/or anticoagulant agents).
Study Type
OBSERVATIONAL
Enrollment
3
John Theurer Cancer Center at Hackensack UMC (Site 128)
Hackensack, New Jersey, United States
Hudson Valley Hematology Oncology Associates (Site 236)
Hawthorne, New York, United States
The incidence of Vascular Occlusive Events (VOEs) including, but not limited to: myocardial infarction, cerebrovascular ischemic disease, peripheral artery occlusive disease and venous thromboembolism
All VOEs will be entered into the EDC (Electronic Data Capture system)
Time frame: 54 months
Number of participants with the risk factors for development of VOEs
Subject medical history and family medical history will be entered into the EDC
Time frame: 54 months
Composite outcome measure of VOEs
The category/type of outcome (e.g. Death, Disability/Permanent Damage, Hospitalization, Other), the time of duration, and status (continuing, resolved, fatal) will be entered into the EDC.
Time frame: 54 months
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