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Business Decision; Insufficient Enrollment
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| Name | Class |
|---|---|
| United BioSource, LLC | INDUSTRY |
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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).
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with CP-CML, AP-CML, BP-CML, or Ph+ALL for whom the decision to initiate treatment with commercially available Iclusig has already been made
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Theurer Cancer Center at Hackensack UMC (Site 128) | Hackensack | New Jersey | 07601 | United States | ||
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| Label | URL |
|---|---|
| Iclusig US Prescribing Information | View source |
| To obtain more information on the study, click this link. | View source |
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| Hudson Valley Hematology Oncology Associates (Site 236) |
| Hawthorne |
| New York |
| 10532 |
| United States |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D001752 | Blast Crisis |
| D007938 | Leukemia |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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