Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients

Completed · Phase 2/Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

The purpose of this study is 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 AML patients.

Key facts

Study ID

NCT00952588

Run by

AstraZeneca

People needed

74

Starts

2009-07-01

Expected to finish

2011-06-01

Last updated by the study team

2020-02-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of written informed consent
• Newly diagnosed male or female patients aged 60 and over
• De Novo or Secondary AML
• Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following:Age ≥75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia

You may not qualify if…

• 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

Where it is running

• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — New York, New York, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Westmead, New South Wales, Australia
• Research Site — Herston, Queensland, Australia
• Research Site — Melbourne, Victoria, Australia
• Research Site — Parkville, Victoria, Australia
• Research Site — Angers, France
• Research Site — Clermont-Ferrand, France
• Research Site — Grenoble, France
• Research Site — Lyon, France
• Research Site — Marseille, France
• Research Site — Nantes, France
• Research Site — Duisburg, Germany
• Research Site — Erlangen, Germany
• Research Site — Frankfurt, Germany
• Research Site — Münster, Germany
• Research Site — Villingen-Schwenningen, Germany
• Research Site — Bologna, BO, Italy
• Research Site — Genova, GE, Italy

Full record on ClinicalTrials.gov

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