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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.
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.
Secondary ID [1] 282163 0
None
Universal Trial Number (UTN)
U1111-1140-9478
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myelodysplasia 288674 0
acute myeloid leukaemia 288675 0
Condition category
Condition code
Blood 289025 289025 0 0
Haematological diseases
Cancer 289026 289026 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286771 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289141 0
% mean survival
Timepoint [1] 289141 0
18 months
Secondary outcome [1] 301913 0
Haematological improvement in at least one cytopenia
Timepoint [1] 301913 0
4-18 months
Monthly assessment of cytopenias.
Secondary outcome [2] 301914 0
Decreased transfusion requirement.
Timepoint [2] 301914 0
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)

Eligibility
Key inclusion criteria
>65 years old
Diagnosis of high-risk myelodysplasia or acute myeloid leukaemia on bone marrow biopsy.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Azacitidine use contraindicated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 787 0
Illawarra Private Cancer Care & Research Centre - Wollongong
Recruitment postcode(s) [1] 6598 0
2500 - Wollongong
Recruitment postcode(s) [2] 6600 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 286935 0
Charities/Societies/Foundations
Name [1] 286935 0
Southern Haematology and Cancer Research Institute
Country [1] 286935 0
Australia
Primary sponsor type
Hospital
Name
Illawarra Private Cancer Care Centre
Address
35 Denison St
Wollongong
NSW 2500
Country
Australia
Secondary sponsor category [1] 285724 0
None
Name [1] 285724 0
Address [1] 285724 0
Country [1] 285724 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288991 0
University of Wollongong and the Illawarra Shoalhaven Local Health District Health and Medical HREC
Ethics committee address [1] 288991 0
Research Services Office
Building 20, Level 1
University of Wollongong,
Northfields Ave
Wollongong NSW 2522
Ethics committee country [1] 288991 0
Australia
Date submitted for ethics approval [1] 288991 0
25/03/2013
Approval date [1] 288991 0
Ethics approval number [1] 288991 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38658 0
A/Prof Rajeev Ramakrishna
Address 38658 0
Illawarra Private Cancer Care Centre
35 Denison St
Wollongong
NSW 2500
Country 38658 0
Australia
Phone 38658 0
+61242299400
Fax 38658 0
Email 38658 0
[email protected]
Contact person for public queries
Name 38659 0
William Alexander
Address 38659 0
Illawarra Private Cancer Care Centre
35 Denison St
Wollongong
NSW 2500
Country 38659 0
Australia
Phone 38659 0
+61242299400
Fax 38659 0
Email 38659 0
[email protected]
Contact person for scientific queries
Name 38660 0
William Alexander
Address 38660 0
Illawarra Private Cancer Care Centre
35 Denison St
Wollongong
NSW 2500
Country 38660 0
Australia
Phone 38660 0
+61242299400
Fax 38660 0
Email 38660 0
[email protected]

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.