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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02455024
Recruitment Status : Terminated (Business Decision; Insufficient Enrollment)
First Posted : May 27, 2015
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
United BioSource, LLC
Information provided by (Responsible Party):
Takeda ( Ariad Pharmaceuticals )

Study Description
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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).
Study Design
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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 : March 2, 2018
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : February 19, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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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.


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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United States, New Jersey
John Theurer Cancer Center at Hackensack UMC (Site 128)
Hackensack, New Jersey, United States, 07601
United States, New York
Hudson Valley Hematology Oncology Associates (Site 236)
Hawthorne, New York, United States, 10532
Sponsors and Collaborators
Ariad Pharmaceuticals
United BioSource, LLC
More Information
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Additional Information:

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Responsible Party: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02455024    
Other Study ID Numbers: AP24534-14-401
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Keywords provided by Takeda ( Ariad Pharmaceuticals ):
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
Additional relevant MeSH terms:
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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