Clinical trial NCT02455024: An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG®
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).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL
Keywords: 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
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: United BioSource, LLC
First posted: 2015-05-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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).

Eligibility 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.

Primary outcomes:
measure: The incidence of Vascular Occlusive Events (VOEs) including, but not limited to: myocardial infarction, cerebrovascular ischemic disease, peripheral artery occlusive disease and venous thromboembolism
timeFrame: 54 months
measure: Number of participants with the risk factors for development of VOEs
timeFrame: 54 months
measure: Composite outcome measure of VOEs
timeFrame: 54 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack UMC (Site 128)
state: New Jersey
city: Hawthorne
country: United States
facility: Hudson Valley Hematology Oncology Associates (Site 236)
state: New York
Study officials:
References: