CLAVELA - Pivotal Phase III study in relapsed or refractory acute myeloid leukemia (AML)
CLAVELA is a Phase III open-label randomised, controlled study comparing elacytarabine with the investigator’s choice of treatment in patients with relapsed or refractory AML. CLAVELA will enrol approximately 380 patients across 75 sites in North America, Europe and Australia.
The primary objective of the study is to compare the overall survival of elacytarabine and investigator's choice. Top-line data are expected in Q1 2013.
CP4055-205 - Study in early stage AML
The CP4055-205 study is a single-arm Phase II study of elacytarabine plus idarubicin given to AML patients who failed to respond
to a first line cytarabine containing regime. The study is testing the efficacy and safety of elacytarabine plus idarubicin
after failure of one previous cytarabine based induction treatment and the association between hENT1 expression on leukemic
blast cells and the response to both cytarabine and elacytarabine.
Fifty-one (51) patients were enrolled across 10 sites in Europe and USA. The patients will be followed up for survival until October 2013.
The primary objective of the study is to determine the rate of complete remission.
CP4055-109 - Pharmacokinetic study
This is an open label, single arm study designed to evaluate the pharmacokinetic as well as the cardiac safety of elacytarabine in patients with relapsed or refractory AML. Fourty-three (43) patients were enrolled at 6 sites in UK and Spain. The patients will be followed up for survival until May 2013.