Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
|ClinicalTrials.gov Identifier: NCT01650805|
Recruitment Status : Terminated (Study terminated based on evaluation of safety data.)
First Posted : July 26, 2012
Results First Posted : October 21, 2014
Last Update Posted : November 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: ponatinib Drug: imatinib (Gleevec/ Glivec)||Phase 3|
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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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||307 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2012|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
45 mg tablet, taken orally once daily
|Active Comparator: imatinib||
Drug: imatinib (Gleevec/ Glivec)
400 mg tablet, taken orally once daily
- Major Molecular Response (MMR) Rate at 12 Months [ Time Frame: 12 months after first dose ]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 ]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 (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib
- Complete Cytogenetic Response (CCyR) Rate [ Time Frame: 12 months after first dose ]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 ]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 ]To compare, according to treatment with ponatinib versus imatinib, overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650805
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