An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG®

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
A Postmarketing Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG® (Ponatinib) in Routine Clinical Practice in the United States (OMNI).

Conditions
-----------------
Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (age ≥18 years) who are diagnosed with CP-CML, AP-CML, BP-CML, or Ph+ ALL Patients who are initiating Iclusig therapy for the first time, or for whom Iclusig therapy was initiated within 30 days before registry enrollment. The decision to prescribe Iclusig must have been made prior to enrollment in the registry and based upon approved US indications. Patients who have the ability to understand the requirements of the registry, and provide written informed consent to comply with the registry data collection procedures. Exclusion Criteria: Patients previously treated with investigational Iclusig. Patients receiving any investigational agent (eg, any drug or biologic agent or medicaldevice that has not received approval in the US) or receiving Iclusig for any indication not currently approved in the US. Concurrent treatment with another TKI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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. | 54 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AP-CML, BP-CML, Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, ponatinib, Pharmacologic Actions, Protein Kinase Inhibitors, Risk factor, Leukemia, Myelogenous, Chronic, CML, CP-CML, Iclusig, AP24534, Ph+ALL