TerminatedNot Applicable

An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG®

Stopped: Business Decision; Insufficient Enrollment

United States3 participantsStarted 2018-03-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

✕. Patients previously treated with investigational Iclusig.
✕. 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.
✕. Concurrent treatment with another TKI.

What they're measuring

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

Number of participants with the risk factors for development of VOEs

Timeframe: 54 months

Composite outcome measure of VOEs

Timeframe: 54 months

Trial details

NCT IDNCT02455024

SponsorAriad Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-02-19

View on ClinicalTrials.gov More Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

✕. Patients previously treated with investigational Iclusig.
✕. 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.
✕. Concurrent treatment with another TKI.

What they're measuring

Timeframe: 54 months

Number of participants with the risk factors for development of VOEs

Timeframe: 54 months

Composite outcome measure of VOEs

Timeframe: 54 months