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

Study title

OPTIC-2L = A Study Comparing Ponatinib and Nilotinib in Patients With Chronic Myeloid Leukemia

Scientific title

A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib (AP24534-15-303) (EudraCT2015-001318-92, NCT02627677)

Type of study

Second line trial after treatment failure

Current status

Active, not recruiting

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.

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 sponsor

Takeda (Previously Ariad Pharmaceuticals)

Scientific lead / contact

Heinrich Farin, MD; Heinrich.Farin@ARIAD.com

Principal investigator

Dr. Violaine Havelange, Cliniques Universitaire Saint-Luc (Site 058), Bruxelles, Belgium, 1200

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