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

NCT ID: NCT02455024

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-02
• Study Completion Date: 2019-02-19

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.

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).

Conditions

Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United BioSource, LLC

INDUSTRY

Sponsor Role: collaborator

Ariad Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Related Links

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203469s009lbl.pdf

Iclusig US Prescribing Information

https://clinicaltrials.takeda.com/study-detail/5f6b601a4db2bf003ab492ed??page=1&idFilter=AP24534-14-401

To obtain more information on the study, click this link.

Other Identifiers

AP24534-14-401

Identifier Type: -

Identifier Source: org_study_id