OPTIC 2L = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
Type of study
Second line trial after treatment failure
Current status
Active, not recruiting
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)
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 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