A Phase II Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia
Elacytarabine (CP-4055) is a pro-drug of ara-C currently used in the treatment of patients
with acute myeloid leukaemia. Patients with nucleoside transporter deficiency (hENT1) seem
to have less benefit from cytarabine compared to those with a high expression of the
transporter. Preclinical studies indicate that elacytarabine is independent of this
transporter. Therefore, patients with low expression of hENT1 and treated with elacytarabine
are anticipated to have a better outcome compared to patients treated with ara-C. The main
objective of this study is to assess the biological activity of elacytarabine in combination
with idarubicin in patients with acute myeloid leukaemia. In addition, the correlation
between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be
studied. Patients will be treated with elacytarabine plus idarubicin independent of their
hENT1 status. Determination of the patients' hENT1 expression level will be done
retrospectively. This study will also explore the safety profile of elacytarabine in
combination with idarubicin.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the rate of complete remission (CR), including complete remission with incomplete blood count recovery (CRi) in patients with AML who have not attained blast clearance after the first course of a ara-C based remission-induction therapy.
Day 21 in each course
Yes
David A Rizzieri, MD
Principal Investigator
Duke University Medical Center, Durham, NC, USA
United States: Food and Drug Administration
CP4055-205
NCT01035502
December 2009
October 2013
Name | Location |
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Duke University Medical Center | Durham, North Carolina 27710 |