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

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.

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack UMC (Site 128)
  • New York
    • Hawthorne, New York, United States, 10532
      • Hudson Valley Hematology Oncology Associates (Site 236)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ariad Pharmaceuticals
• Collaborators: United BioSource, LLC

Publications and helpful links

Helpful Links

• Iclusig US Prescribing Information
• To obtain more information on the study, click this link.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): February 19, 2019
• Study Completion (Actual): February 19, 2019

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimated): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Leukemia; CP-CML; CML; Pharmacologic Actions; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myelogenous, Chronic; Leukemia, Myeloid; Protein Kinase Inhibitors; Iclusig; Ph+ALL; Risk factor; ponatinib; AP24534; AP-CML; BP-CML
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Neoplastic Processes; Cell Transformation, Neoplastic; Carcinogenesis; Leukemia, Myeloid; Chronic Disease; Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis
• Other Study ID Numbers: AP24534-14-401