OMNI = Registry to evaluate vascular occlusive events with Iclusig [USA]
Type of study
Recruitment was stopped due to insufficient enrollment (business decision)
An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With Iclusig® (OMNI)
What is the purpose of the study
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).
Key inclusion criteria
- 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 verbal informed consent to comply with the registry data collection procedures.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Takeda (previously Ariad Pharmaceuticals)
Collaborator: United BioSource Corporation
Scientific lead / contact
Blythe Thomson, MD
For OMNI, there is no principal investigator as this is a registry.
Study centers / principal investigators
John Theurer Cancer Center at Hackensack UMC (Site 128)
Stefan Faderl, MD
Hudson Valley Hematology Oncology Associates (Site 236)
Karen Seiter, MD