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)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, observational registry study

Study drug and medical condition

• Name of medicine:
  ICLUSIG
• Medical condition to be studied:
  Vascular occlusion

Population studied

• Short description of the study population:
  The target registry population will include adult patients in the US who are diagnosed with CP-CML, AP-CML, BP-CML, or Ph+ ALL; who are over 18 years of age; and for whom the decision to initiate treatment with commercially available Iclusig has already been made. Inclusion criteria are broad and exclusion criteria are limited so as to include a representative population of patients being treated with Iclusig in routine clinical practice for one of the current approved indications.; ; Inclusion Criteria; Patients must meet all of the following criteria to be eligible for the registry:; 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; Patients are not eligible for participation in the registry if they meet any of the following exclusion criteria:; 1. Patients previously treated with investigational Iclusig.; 2. Patients receiving any investigational agent (eg, any drug or biologic agent or medical device 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.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The primary objectives of this study are to assess the following for patients with CP-CML AP-CML, BP-CML, or Ph+ ALL treated with Iclusig with or without anticoagulant and/or antiplatelet agents in routine clinical practice in the US: · the incidence of vascular occlusive events (VOEs) · the risk factors for development of VOEs · the outcomes of VOEs
• Outcomes:
  To evaluate the safety of Iclusig in routine care
• Data analysis plan:
  Analyses will include tabulations of the number of candidate patients identified and the number of eligible patients per the inclusion/exclusion criteria. Baseline demographic and medical history data will be presented using descriptive statistics using number and percent for categorical endpoints, n, mean, SD, SE of the mean, median, minimum (min), and maximum (max) for continuous endpoints. The primary analyses will also present 95% CIs. Exploratory analyses will also be performed to better understand any differences in patients who experience any of the adverse events of special interest (VOEs) versus those who do not. The exploratory analyses will be performed using logistic regression, including factors such as patient demographic characteristics, risk factors, dose and duration of Iclusig treatment, and concomitant medications, including but not limited to prophylactic and/or therapeutic use of anticoagulant and/or antiplatelet agents.