Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®)

Incyte

Status: Completed

Conditions: Chronic Myeloid Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT04048564

2017-A01355-48

Details and patient eligibility

About

This is a multicentre ambispective cohort study involving French patients who have started or are receiving for less than 6 months a treatment with ponatinib. This study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with CML patients' therapeutic history.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presenting a CML in any phase.
• Having initiated for less than six months a treatment with ponatinib.
• The ability to understand the requirements of the study and to comply with the study data collection procedures.

Exclusion criteria

• Patients previously treated with investigational ponatinib (within a clinical trial).
• Patients receiving an investigational agent.
• Patients who are pregnant and/or breastfeeding.
• Patients with contraindications for Ponatinib according to Summary of Products Characteristics.