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
SPARK-AML1
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 With Newly Diagnosed Acute Myeloid Leukaemia (AML)
1 other identifier
interventional
74
9 countries
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2009
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
March 31, 2014
CompletedFebruary 24, 2020
February 1, 2020
1.9 years
August 4, 2009
February 1, 2013
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Overall Complete Response for Stage I
Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to \<5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence.
IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Secondary Outcomes (6)
Duration of Response (DoR): Stage I and Transition Phase
DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Disease Free Survival (DFS)
DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Time To Complete Response (TTCR)
Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Overall Survival (OS)
Assessed from randomisation until the date of death from any cause, assessed up to 24 months
Percent of Patients With Worsened Trial Outcome Index (TOI)
TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
- +1 more secondary outcomes
Study Arms (2)
AZD1152 1200 mg
EXPERIMENTALAZD1152 1200 mg, iv, 7 day infusion monotherapy
LDAC 20 mg
ACTIVE COMPARATORLDAC 20 mg, sc, bd, 10 days (400mg per cycle)
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (45)
Research Site
Atlanta, Georgia, United States
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Chicago, Illinois, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Westmead, New South Wales, Australia
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Herston, Queensland, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Angers, France
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Clermont-Ferrand, France
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Grenoble, France
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Lyon, France
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Marseille, France
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Nantes, France
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Duisburg, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Münster, Germany
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Villingen-Schwenningen, Germany
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Bologna, BO, Italy
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Genova, GE, Italy
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Orbassano, TO, Italy
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Udine, UD, Italy
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Roma, Italy
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Nagoya, Aichi-ken, Japan
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Yoshida-gun, Fukui, Japan
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Maebashi, Gunma, Japan
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Isehara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Chūō, Tokyo, Japan
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Fukuoka, Japan
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Brasov, Romania
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TG Mures, Romania
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Badalona(barcelona), Catalonia, Spain
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Barcelona, Catalonia, Spain
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Madrid, Madrid, Spain
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Majadahonda, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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Valencia, Valencia, Spain
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Brighton, United Kingdom
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London, United Kingdom
Related Publications (1)
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.
PMID: 23071272DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Paul Stockman
AstraZeneca
- PRINCIPAL INVESTIGATOR
Hagop Kantarjian
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 24, 2020
Results First Posted
March 31, 2014
Record last verified: 2020-02