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
NCT ID: NCT00952588
Last Updated: 2020-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
74 participants
INTERVENTIONAL
2009-07-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AZD1152 1200 mg
AZD1152 1200 mg, iv, 7 day infusion monotherapy
AZD1152
1200 mg, iv, 7 day infusion
LDAC 20 mg
LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
LDAC
20 mg, sc, bd, 10 days
Interventions
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AZD1152
1200 mg, iv, 7 day infusion
LDAC
20 mg, sc, bd, 10 days
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Stockman
Role: STUDY_DIRECTOR
AstraZeneca
Hagop Kantarjian
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Research Site
Orbassano, TO, Italy
Research Site
Udine, UD, Italy
Research Site
Roma, , Italy
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Yoshida-gun, Fukui, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Chūō, Tokyo, Japan
Research Site
Fukuoka, , Japan
Research Site
Brasov, , Romania
Research Site
TG Mures, , Romania
Research Site
Badalona(barcelona), Catalonia, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Majadahonda, Madrid, Spain
Research Site
Oviedo, Principality of Asturias, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Brighton, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Quintas-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15.
Other Identifiers
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D1531C00009
Identifier Type: -
Identifier Source: org_study_id
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