Clinical trial NCT00952588: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukaemia,
AML
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 74
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Patients With Overall Complete Response for Stage I
timeFrame: IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Secondary outcomes:
measure: Duration of Response (DoR): Stage I and Transition Phase
timeFrame: DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
measure: Disease Free Survival (DFS)
timeFrame: DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
measure: Time To Complete Response (TTCR)
timeFrame: Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
measure: Overall Survival (OS)
timeFrame: Assessed from randomisation until the date of death from any cause, assessed up to 24 months
measure: Percent of Patients With Worsened Trial Outcome Index (TOI)
timeFrame: TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
measure: Percent of Patients With Worsened Functional Assessment of Cancer Therapy - Leukaemia (FACT-Leu) Score.
timeFrame: FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: New York
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Angers Cedex 01
country: France
facility: Research Site
city: Clermont-ferrand
country: France
facility: Research Site
city: Grenoble Cedex 09
country: France
facility: Research Site
city: Lyon Cedex 03
country: France
facility: Research Site
city: Marseille Cedex 09
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Villingen-schwenningen
country: Germany
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Genova
country: Italy
facility: Research Site
state: GE
city: Orbassano
country: Italy
facility: Research Site
state: TO
city: Udine
country: Italy
facility: Research Site
state: UD
city: Roma
country: Italy
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Yoshida-gun
country: Japan
facility: Research Site
state: Fukui
city: Maebashi
country: Japan
facility: Research Site
state: Gunma
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: TG Mures
country: Romania
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Badalona(barcelona)
country: Spain
facility: Research Site
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad DE Madrid
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Brighton
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Paul Stockman
role: STUDY_DIRECTOR
affiliation: M.D. Anderson Cancer Center
name: Hagop Kantarjian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.