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



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:March 2, 2018
End Date:September 30, 2020
Contact:Blythe Thomson, MD
Email:Blythe.Thomson@ariad.com
Phone:(617) 494-0400

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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).

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).

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.
We found this trial at
2
sites
Hawthorne, New York 10532
Principal Investigator: Karen Seiter, M.D.
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from
Hawthorne, NY
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Hackensack, New Jersey 07601
Principal Investigator: Stefan Faderl, MD
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from
Hackensack, NJ
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