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OMNI = Registry to evaluate vascular occlusive events with Iclusig [US]

Study title

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

Scientific 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 US (OMNI) (ClinicalTrials.gov NCT02455024)

Indication and most important inclusion criteria

Adult patients with chronic myeloid leukemia in chronic phase (CP-CML), chronic myeloid leukemia in accelerated phase (AP-CML), chronic myeloid leukemia in blast phase (BP-CML), or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom the decision to initiate treatment with commercially available Iclusig has already been made
 

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 verbal informed consent to comply with the registry data collection procedures.

Short description of intervention

Additional information is needed to characterize the safety profile of Iclusig as it is used in routine clinical practice in the US. 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). 

Type of study

Other trials

Current status

Recruiting

Study sponsor

Ariad Pharmaceuticals (recently acquired by Takeda)
Collaborator: United BioSource Corporation

Scientific lead / contact

Blythe Thomson, MD

Principal investigator

For OMNI, there is no principal investigator as this is a registry.

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

EU PAS register

Study centers / principal investigators

United States

New Jersey
Hackensack, 07601
John Theurer Cancer Center at Hackensack UMC (Site 128)
Stefan Faderl, MD

New York
Hawthorne, 10532
Hudson Valley Hematology Oncology Associates (Site 236)
Karen Seiter, MD