Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
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.
Chronic Myeloid Leukemia
Drug: imatinib (Gleevec/ Glivec)
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|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase|
- Major Molecular Response (MMR) Rate at 12 Months [ Time Frame: 12 months after first dose ] [ Designated as safety issue: No ]A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.
- MMR Rate [ Time Frame: 5 years after first dose ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib
- Complete Cytogenetic Response (CCyR) Rate [ Time Frame: 12 months after first dose ] [ Designated as safety issue: No ]The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.
- Progression-free Survival [ Time Frame: Up to 8 years after the last patient's first dose ] [ Designated as safety issue: No ]To compare, according to treatment with ponatinib versus imatinib, progression-free survival
- Overall Survival [ Time Frame: Up to 8 years after the last patient's first dose ] [ Designated as safety issue: No ]To compare, according to treatment with ponatinib versus imatinib, overall survival
|Study Start Date:||June 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
45 mg tablet, taken orally once daily
|Active Comparator: imatinib||
Drug: imatinib (Gleevec/ Glivec)
400 mg tablet, taken orally once daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650805
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