NCT01650805

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Ariad Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

Detailed description

This multicenter, international, phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib. Patients will be randomized in a 1:1 fashion, stratified by Sokal risk score at diagnosis (low, intermediate, high), to receive once daily oral administration of either ponatinib or imatinib. Efficacy measures include molecular, cytogenetic, and hematologic response rates at various timepoints; time to, duration of, and durability of responses; and survival follow-up. Safety measures include clinical laboratory testing, adverse event monitoring, vital signs, physical exams, ECGs, and ECHOs. Other measures include two patient-reported health outcomes questionnaires (FACT-Leu and EQ-5D-5L), determination of mutation status, and, for ponatinib only, measurement of steady-state plasma concentration. Accrual is expected to take approximately 2 years, and patients will be followed for survival for up to 8 years after the last patient's first dose; therefore, patient participation may last up to 10 years.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	ponatinib	45 mg tablet, taken orally once daily
DRUG	imatinib (Gleevec/ Glivec)	400 mg tablet, taken orally once daily

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-07-26
• Last updated: 2014-11-17
• Results posted: 2014-10-21

Locations

170 sites across 24 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom