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Trial registered on ANZCTR
Registration number
ACTRN12613000358741
Ethics application status
Not yet submitted
Date submitted
22/03/2013
Date registered
5/04/2013
Date last updated
5/04/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Azacitidine use in elderly patients (over 65) with high risk myelodysplasia/acute myeloid leukaemia.
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Scientific title
The effect of subcutaneous azacitidine on overall survival using the alternate regimen of 75mg/m2/day for 3 days/week (Monday, Wednesday, Friday) for 2 weeks each month in elderly patients (over 65 years old) with high risk myelodysplasia/acute myeloid leukaemia.
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Secondary ID [1]
282163
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None
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Universal Trial Number (UTN)
U1111-1140-9478
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
myelodysplasia
288674
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acute myeloid leukaemia
288675
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Condition category
Condition code
Blood
289025
289025
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0
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Haematological diseases
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Cancer
289026
289026
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0
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Leukaemia - Acute leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients with high risk myelodysplasia/acute myeloid leukaemia administered azacitidine 75mg/m2 subcutaneously 3 times a week (Monday, Wednesday, Friday) for two consecutive weeks every 4 weeks until unacceptable toxicity, failure of therapy to show improvement in cytopenia, or disease progression/death.
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Intervention code [1]
286771
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Treatment: Drugs
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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% mean survival
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Assessment method [1]
289141
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Timepoint [1]
289141
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18 months
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Secondary outcome [1]
301913
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Haematological improvement in at least one cytopenia
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Assessment method [1]
301913
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Timepoint [1]
301913
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4-18 months
Monthly assessment of cytopenias.
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Secondary outcome [2]
301914
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Decreased transfusion requirement.
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Assessment method [2]
301914
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Timepoint [2]
301914
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4-18 months
Ongoing assessment of transfusion required. For example, if the gap between transfusions moves from 2 weeks to 3 weeks, this is an improvement. Each participant has the record of the transfusion requirement updated each time they are transfused (variable time between participants)
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Eligibility
Key inclusion criteria
>65 years old
Diagnosis of high-risk myelodysplasia or acute myeloid leukaemia on bone marrow biopsy.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Azacitidine use contraindicated.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/04/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
787
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Illawarra Private Cancer Care & Research Centre - Wollongong
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Recruitment postcode(s) [1]
6598
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2500 - Wollongong
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Recruitment postcode(s) [2]
6600
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2217 - Kogarah
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Funding & Sponsors
Funding source category [1]
286935
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Charities/Societies/Foundations
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Name [1]
286935
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Southern Haematology and Cancer Research Institute
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Address [1]
286935
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35 Denison St
Wollongong
NSW 2500
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Country [1]
286935
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Australia
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Primary sponsor type
Hospital
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Name
Illawarra Private Cancer Care Centre
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Address
35 Denison St
Wollongong
NSW 2500
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Country
Australia
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Secondary sponsor category [1]
285724
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None
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Name [1]
285724
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Address [1]
285724
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Country [1]
285724
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
288991
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University of Wollongong and the Illawarra Shoalhaven Local Health District Health and Medical HREC
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Ethics committee address [1]
288991
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Research Services Office
Building 20, Level 1
University of Wollongong,
Northfields Ave
Wollongong NSW 2522
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Ethics committee country [1]
288991
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Australia
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Date submitted for ethics approval [1]
288991
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25/03/2013
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Approval date [1]
288991
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Ethics approval number [1]
288991
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Summary
Brief summary
This study is evaluating the effect of less frequent azacitidine treatment in elderly patients with high risk myelodysplasia/acute myeloid leukaemia. Who is it for? You may be eligible to join this study if you are aged over 65 years and have been diagnosed with high risk myelodysplasia or acute myeloid leukaemia on bone marrow biopsy. Trial details: All participants in this trial will received the drug azacitidine at a dose of 75mg/m2 three times a week (Monday, Wednesday, Friday) for two consecutive weeks every 4 weeks. Participants will be assessed for up to 18 months post treatment in order to evaluate survival and response to treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Rajeev Ramakrishna
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Address
38658
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Illawarra Private Cancer Care Centre
35 Denison St
Wollongong
NSW 2500
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Country
38658
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Australia
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Phone
38658
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+61242299400
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Fax
38658
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Email
38658
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[email protected]
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Contact person for public queries
Name
38659
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Mr William Alexander
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Address
38659
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Illawarra Private Cancer Care Centre
35 Denison St
Wollongong
NSW 2500
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Country
38659
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Australia
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Phone
38659
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+61242299400
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Fax
38659
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Email
38659
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[email protected]
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Contact person for scientific queries
Name
38660
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Mr William Alexander
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Address
38660
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Illawarra Private Cancer Care Centre
35 Denison St
Wollongong
NSW 2500
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Country
38660
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Australia
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Phone
38660
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+61242299400
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Fax
38660
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Email
38660
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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