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

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ClinicalTrials.gov Identifier: NCT02455024
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
United BioSource Corporation
Information provided by (Responsible Party):
Takeda ( Ariad Pharmaceuticals )

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
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).

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Study Type : Observational
Estimated Enrollment : 300 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 : March 2, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020





Primary Outcome Measures :
  1. The incidence of Vascular Occlusive Events (VOEs) including, but not limited to: myocardial infarction, cerebrovascular ischemic disease, peripheral artery occlusive disease and venous thromboembolism [ Time Frame: 54 months ]
    All VOEs will be entered into the EDC (Electronic Data Capture system)

  2. Number of participants with the risk factors for development of VOEs [ Time Frame: 54 months ]
    Subject medical history and family medical history will be entered into the EDC

  3. Composite outcome measure of VOEs [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455024


Contacts
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Contact: Blythe Thomson, MD (617) 494-0400 Blythe.Thomson@ariad.com

Locations
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United States, New Jersey
John Theurer Cancer Center at Hackensack UMC (Site 128) Recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Stefan Faderl, MD         
United States, New York
Hudson Valley Hematology Oncology Associates (Site 236) Recruiting
Hawthorne, New York, United States, 10532
Principal Investigator: Karen Seiter, M.D.         
Sponsors and Collaborators
Ariad Pharmaceuticals
United BioSource Corporation

Additional Information:
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Responsible Party: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02455024     History of Changes
Other Study ID Numbers: AP24534-14-401
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Keywords provided by Takeda ( Ariad Pharmaceuticals ):
Protein Kinase Inhibitors
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
ponatinib
Pharmacologic Actions
Risk factor
Leukemia, Myelogenous, Chronic
CML
CP-CML
Iclusig
AP24534
AP-CML
BP-CML
Ph+ALL
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Enzyme Inhibitors
Leukemia
Blast Crisis
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Ponatinib
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action