A Randomised, Open-label, Multi-centre, 2-stage, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC) in Comparison With LDAC Alone in Patients Aged 60 or more With Newly Diagnosed Acute Myeloid Leukaemia (AML)
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- JPRN-jRCT2080220925
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the followings
-Age at 75 years or more
-Adverse cytogenetics, eg as defined by the MRC Prognostic Groupings
-WHO performance status 3 or more
-Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia
-Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
-Administration of LDAC is clinically contraindicated
-Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
-Patients with blast crisis of chronic myeloid leukaemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method