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
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
Recruitment was stopped due to insufficient enrollment (business decision)
Study sponsor
Takeda (previously Ariad Pharmaceuticals)
Collaborator: United BioSource Corporation
Scientific lead / contact
Blythe Thomson, MD
Blythe.Thomson@ariad.com
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
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Philadelphia chromosome
A certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene)
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
cardiovascular
Cardiovascular disease (also called heart disease) is a class of diseases that involve the heart, the blood vessels (arteries, capillaries, and veins) or both
Chronic phase
The earliest phase of CML development.
Chromosome
A chromosome is a structure of DNA that carries the genetic makeup in the nucleus of the cell. Chromosomes contain giant chain molecules of DNA, coiled and folded as aggregates with specific proteins. Chromosomes ensure that during cell division the hereditary information is evenly distributed to the daughter cells. Normal human body cells have 46 chromosomes. Cancer cells can have a different number and/or structure of chromosomes.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Incidence
The number of new cases of a specific disease occurring during a certain period, e.g. one year
Ponatinib
Trade name: Iclusig, development name: AP24534; a third-generation tyrosine kinase inhibitor
Other names: AP24534|Iclusig.
Chronic
Long-lasting, slowly developping
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
Acute
Of sudden onset, severe; of short duration.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Ph+
Abbreviation for "Philadelphia-Chromosome-positive", meaning the presence of a certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene).
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
