Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL Clinical Trial
— OMNIOfficial 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).
| Verified date | April 2024 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | February 19, 2019 |
| Est. primary completion date | February 19, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Adult patients (age =18 years) who are diagnosed with CP-CML, AP-CML, BP-CML, or Ph+ ALL 2. Patients who are initiating Iclusig therapy for the first time, or for whom Iclusig therapy was initiated within 30 days before registry enrollment. 3. The decision to prescribe Iclusig must have been made prior to enrollment in the registry and based upon approved US indications. 4. 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: 1. Patients previously treated with investigational Iclusig. 2. 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. 3. Concurrent treatment with another TKI. |
| Country | Name | City | State |
|---|---|---|---|
| United States | John Theurer Cancer Center at Hackensack UMC (Site 128) | Hackensack | New Jersey |
| United States | Hudson Valley Hematology Oncology Associates (Site 236) | Hawthorne | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Ariad Pharmaceuticals | United BioSource, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |