OPTIC 2L = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]

What is the purpose of the study

This is a study to demonstrate the efficacy and safety of 2 starting doses of ponatinib (30 and 15 mg once daily) as a treatment for CP-CML compared to nilotinib (400 mg twice daily), as measured by major molecular response (MMR) by 12 months.

What will happen during the study

Key inclusion criteria

This study includes patients who:
– have chronic myeloid leukemia in chronic phase (CP-CML) and are resistant to first-line imatinib treatment
– are at least 18 years old, have an Eastern Co-Operative Group (ECOG) status of 0-1, have given written informed consent and comply with scheduled visits and study procedures
– have adequate kidney and liver function as well as normal pancreatic status
– have a negative pregnancy test, use a highly effective form of contraception from randomization through at least 4 months after the end of treatment (for female and male patients who are fertile)
– have fully recovered from the acute effects of prior cancer therapy (hydroxyurea or imatinib) before initiation of study drug

Additional criteria apply.

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

The study is being performed in the following countries:

Argentina, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Netherlands, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, UK