Vosaroxin and cytarabine vs placebo and cytarabine in AML patients
Research type
Research Study
Full title
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
IRAS ID
64295
Contact name
Jonathan Kell
Sponsor organisation
Sunesis Pharmaceuticals
Eudract number
2010-021961-61
Clinicaltrials.gov Identifier
Research summary
This is a study in approximately 500 patients (>18 years old) with Acute Myeloid Leukaemia (AML). The standard treatment for newly diagnosed AML has not changed much in the last few decades. Initial treatment usually consists of an anthracycline (eg, daunorubicin or idarubicin) combined with cytarabine, delivered in two phases. The first phase, induction, attempts to clear bone marrow of leukaemic cells to achieve complete remission (CR). The second phase is consolidation to eliminate residual disease and maintain the remission. There are 2 arms to this study to which patients will be randomised equally. Arm 1; Vosaroxin (study drug) and cytarabine, Arm 2: Placebo and cytarabine. Treatment will be provided in cycles, up to a maximum of 4 cycles. Each cycle will last approximately 2-8 weeks, and patients will receive Vosaroxin or placebo on days 1 and 4, and cytarabine on days 1-5. Progression to the next cycle will be at the study doctors discretion dependent on the health of the participant. Due to the drug being delivered intravenously - the study sites will all be hospital sites in the UK. Following the last cycle of treatment that the participant receives, they will enter a 3 year follow up phase of the study, where general information about their health and disease progression will be collected. Various safety measures will be taken throughout the study to confirm the participants eligibility and check on their health throughout the trial. These include an ECG (or MUGA), blood sampling and bone marrow samples.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
11/S0501/7
Date of REC Opinion
8 Apr 2011
REC opinion
Further Information Favourable Opinion