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

NCT02455024 | Terminated

• 1 other identifier: AP24534-14-401
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; ponatinib; Pharmacologic Actions; Protein Kinase Inhibitors; Risk factor; Leukemia, Myelogenous, Chronic; CML; CP-CML; Iclusig; AP24534; AP-CML; BP-CML; Ph+ALL

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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.

Sponsors & Collaborators

• Ariad Pharmaceuticals: lead
• United BioSource, LLC: collaborator

Study Sites (2)

John Theurer Cancer Center at Hackensack UMC (Site 128)

Hackensack, New Jersey, 07601, United States

Location

Hudson Valley Hematology Oncology Associates (Site 236)

Hawthorne, New York, 10532, United States

Location

Related Links

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

MeSH Terms

Conditions

Leukemia, Myeloid; Blast Crisis; Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: May 27, 2015
• Study Start: March 2, 2018
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

US (2)