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

Sponsor

Ariad Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT02455024

Collaborator

United BioSource, LLC (Industry)

Enrollment

Locations

11.6

Actual Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL

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).

Study Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Other

Time Perspective:

Prospective

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).

Actual Study Start Date :

Mar 2, 2018

Actual Primary Completion Date :

Feb 19, 2019

Actual Study Completion Date :

Feb 19, 2019

Outcome Measures

Primary Outcome Measures

The incidence of Vascular Occlusive Events (VOEs) including, but not limited to: myocardial infarction, cerebrovascular ischemic disease, peripheral artery occlusive disease and venous thromboembolism [54 months]
All VOEs will be entered into the EDC (Electronic Data Capture system)
Number of participants with the risk factors for development of VOEs [54 months]
Subject medical history and family medical history will be entered into the EDC
Composite outcome measure of VOEs [54 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Theurer Cancer Center at Hackensack UMC (Site 128)	Hackensack	New Jersey	United States	07601
2	Hudson Valley Hematology Oncology Associates (Site 236)	Hawthorne	New York	United States	10532