coiaward2010

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)

Indication and most important 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.

Short description of intervention

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.

Type of study

Second line trial after treatment failure

Current status

Recruiting

Study sponsor

Ariad Pharmaceuticals (acquired by Takeda)

Scientific lead / contact

Heinrich Farin, MD;

Principal investigator

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

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