EPIC lll is not yet open in UK, but is currently recruiting in US, Canada, Germany, Korea and Singapore for Newly diagnosed CML in chronic phase within 6 months of diagnosis and without any prior treatment apart from hydroxycarbamide (hydroxyurea) and/or anagrelide.
see link for details.
The EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients. The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of major molecular response (MMR) rate at 12 months. Expectation of complete patient enrollment in the trial is by the end of 2013.
The EPIC trial is a randomized, two-arm, multicenter trial that compares the efficacy of ponatinib with that of imatinib in adult patients with newly diagnosed CML in the chronic phase. The trial will be conducted at up to 175 investigational sites in North America, Europe and Asia-Pacific.
Patients in the trial must be at least 18 years of age and diagnosed with CML within six months prior to enrollment.
Approximately 500 patients will be randomized 1:1 to standard doses of ponatinib (45 mg given orally once daily) or imatinib (400 mg given orally once daily). Escalation of the imatinib dose to 600 mg or 800 mg per day is permitted.
The MMR rate at 12 months of treatment is the primary endpoint of the trial. Key secondary endpoints include: MMR at five years, molecular response at three months (a reduction in the level of BCR-ABL transcripts to 10% or less), complete cytogenetic response rate at 12 months, progression-free survival and overall survival.
Each patient will be followed for up to eight years from the time the last patient is randomized to either treatment arm.
The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in 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 dose (400mg) 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) and determination of mutation status.
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
Primary Outcome Measures:
Major Molecular response (MMR) rate [ Time Frame: 12 months after first dose ]
To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
Secondary Outcome Measures:
* MMR rate [ Time Frame: 5 years after first dose ]
To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years
* <10% BCR-ABL ^IS rate [Time Frame: 3 months after first dose ]
To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (IS), in patients administered ponatinib versus those administered imatinib
http://clinicaltrials.gov/ct2/show/NCT01650805?term=ponatinib&rank=7