An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG®
Stopped early
Conditions studied: Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL
In brief
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.
Key facts
- Study ID
- NCT02455024
- Run by
- Ariad Pharmaceuticals
- People needed
- 3
- Starts
- 2018-03-02
- Expected to finish
- 2019-02-19
- Last updated by the study team
- 2024-04-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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