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Acute Myeloid LeukemiaPhase 2/3SPARK-AML1NCT00952588

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

A Phase 2/3 study testing AZD1152 and LDAC in people with Acute Myeloid Leukemia, run by AstraZeneca at 45 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
AZD1152 and LDAC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
45 sitesin 9 countries
Study dates
Jul 2009to Jun 2011
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

45 sites in 9 countries.

45 sites in 9 countries

United States8 sites

  • Research Site

    Atlanta, Georgia

  • Research Site

    Chicago, Illinois

  • Research Site

    Cleveland, Ohio

  • Research Site

    Greenville, South Carolina

  • Research Site

    Houston, Texas

  • Research Site

    Nashville, Tennessee

  • Research Site

    New York, New York

  • Research Site

    Portland, Oregon

Other trials in United States

Japan7 sites

  • Research Site

    Chūō, Tokyo

  • Research Site

    Fukuoka

  • Research Site

    Isehara, Kanagawa

  • Research Site

    Maebashi, Gunma

  • Research Site

    Nagoya, Aichi-ken

  • Research Site

    Yokohama, Kanagawa

  • Research Site

    Yoshida-gun, Fukui

Other trials in Japan

France6 sites

  • Research Site

    Angers

  • Research Site

    Clermont-Ferrand

  • Research Site

    Grenoble

  • Research Site

    Lyon

  • Research Site

    Marseille

  • Research Site

    Nantes

Other trials in France

Spain6 sites

  • Research Site

    Badalona(barcelona), Catalonia

  • Research Site

    Barcelona, Catalonia

  • Research Site

    Madrid, Madrid

  • Research Site

    Majadahonda, Madrid

  • Research Site

    Oviedo, Principality of Asturias

  • Research Site

    Valencia, Valencia

Other trials in Spain

Germany5 sites

  • Research Site

    Duisburg

  • Research Site

    Erlangen

  • Research Site

    Frankfurt

  • Research Site

    Münster

  • Research Site

    Villingen-Schwenningen

Other trials in Germany

Italy5 sites

  • Research Site

    Bologna, BO

  • Research Site

    Genova, GE

  • Research Site

    Orbassano, TO

  • Research Site

    Roma

  • Research Site

    Udine, UD

Other trials in Italy

Australia4 sites

  • Research Site

    Herston, Queensland

  • Research Site

    Melbourne, Victoria

  • Research Site

    Parkville, Victoria

  • Research Site

    Westmead, New South Wales

Other trials in Australia

Romania2 sites

  • Research Site

    Brasov

  • Research Site

    TG Mures

Other trials in Romania

United Kingdom2 sites

  • Research Site

    Brighton

  • Research Site

    London

Other trials in United Kingdom

About this study

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)

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.

Being tested
AZD1152, LDAC
Keywords
Acute Myeloid Leukaemia,, AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD1152Drug

    1200 mg, iv, 7 day infusion

  • LDACDrug

    20 mg, sc, bd, 10 days

Study groups in NCT00952588
Study groupRoleWhat they receive
AZD1152 1200 mgExperimentalAZD1152 1200 mg, iv, 7 day infusion monotherapy
Receives: Drug: AZD1152
LDAC 20 mgActive comparatorLDAC 20 mg, sc, bd, 10 days (400mg per cycle)
Receives: Drug: LDAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)

Secondary outcomes (6)

  1. Duration of Response (DoR): Stage I and Transition Phase

    DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I.

    Measured: DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)

  2. Disease Free Survival (DFS)

    Disease-free Survival is defined as the time from randomisation to relapse or death from any cause.

    Measured: DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)

  3. Time To Complete Response (TTCR)

    TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)

    Measured: Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)

  4. Overall Survival (OS)

    Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive.

    Measured: Assessed from randomisation until the date of death from any cause, assessed up to 24 months

  5. Percent of Patients With Worsened Trial Outcome Index (TOI)

    TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -9.

    Measured: TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)

  6. Percent of Patients With Worsened Functional Assessment of Cancer Therapy - Leukaemia (FACT-Leu) Score.

    The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -11.

    Measured: FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00952588
Sponsor's protocol ID
D1531C00009
Acronym
SPARK-AML1
Status last verified
Feb 2020
First submitted
4 Aug 2009
Last updated
24 Feb 2020

Publications

  • 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.

    PubMed 23071272

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AZD1152 and LDAC in people with Acute Myeloid Leukemia, run by AstraZeneca at 45 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Japan, France, Spain, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Overall Complete Response for Stage I (time frame: IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00952588, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

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