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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12605000152628
Ethics application status
Approved
Date submitted
12/08/2005
Date registered
15/08/2005
Date last updated
15/09/2023
Date data sharing statement initially provided
15/09/2023
Date results information initially provided
15/09/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
A phase II trial of high dose cytarabine and fludarabine without anthracycline for patients with core binding factor acute myeloid leukaemia, measuring efficacy, safety and monitoring minimal residual disease
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Scientific title
A phase II trial of high dose cytarabine and fludarabine without anthracycline for patients with core binding factor acute myeloid leukaemia, measuring efficacy, safety and monitoring minimal residual disease
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Secondary ID [1]
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Australasian Leukaemia and Lymphoma Group (ALLG): ALLG AMLM13
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Secondary ID [2]
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National Clinical Trials Registry: NCTR555
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Universal Trial Number (UTN)
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Trial acronym
CBF-AML
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Core binding factor acute myeloid leukaemia
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Condition category
Condition code
Cancer
276
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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 CBF leukaemia will be treated with high dose Cytarabine and Fludarabine chemotherapy. An induction course will be followed by 6 consolidation cycles 3 of which are Cytarabine alone and 3 of which are fludarabine & cytarabine in combination but in lower total doses than in the induction cycle. Total treatment time will be 7 to 9 months. In addition, minimal residual disease will be monitored using sensitive laboratory methods at 1 and 3 monthly intervals for blood and bone marrow respectively.
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Intervention code [1]
182
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Treatment: Drugs
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Comparator / control treatment
there is no compatator/control treatment in this trial
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To establish the failure-free (FFS) rates of patients with newly diagnosed core binding factor (CBF) acute myeloid leukaemia (AML) treated with high-dose cytarabine (Ara-C) containing regimens exclusive of anthracyclines.
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Assessment method [1]
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Timepoint [1]
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The first analysis of FFS will take place 12 months after the last-registered patient has commenced treatment. If appropriate, the final analysis will take place after all patients have had a minimum potential follow-up of 4 years from the attainment of a complete response (CR).
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Primary outcome [2]
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To establish the overall survival (OS) rates of patients with newly diagnosed core binding factor (CBF) acute myeloid leukaemia (AML) treated with high-dose cytarabine (Ara-C) containing regimens exclusive of anthracyclines.
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Assessment method [2]
326
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Timepoint [2]
326
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The first analysis of OS will take place 12 months after the last-registered patient has commenced treatment. If appropriate, the final analysis will take place after all patients have had a minimum potential follow-up of 4 years from the attainment of a complete response (CR).
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Secondary outcome [1]
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1. To estimate the percentage of patients achieving CR with this treatment approach.
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Assessment method [1]
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Timepoint [1]
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For each patient, this will be assessed 50 days post commencement of induction therapy.
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Secondary outcome [2]
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2. To estimate the leukaemia-free survival (LFS) rate for patients who achieve CR with protocol treatment.
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Assessment method [2]
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Timepoint [2]
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The first analysis of LFS will take place 12 months after the last-registered patient has commenced treatment. If appropriate, the final analysis will take place after all patients have had a minimum potential follow-up of 4 years from the attainment of a complete response (CR).
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Secondary outcome [3]
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3. To determine the safety and tolerability of the protocol treatment.
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Assessment method [3]
726
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Timepoint [3]
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Monitored continuously and independently reviewed every 6 months.
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Secondary outcome [4]
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4. To identify the proportion of patients with CBF AML with cryptic rearrangements (cytogenetically silent).
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Assessment method [4]
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Timepoint [4]
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Assessed at diagnosis.
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Secondary outcome [5]
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5. To monitor the levels of CBF fusion transcripts in PB and BM by quantitative real time polymerase chain reaction (Q-PCR) during therapy and remission and hence to establish the kinetics of leukaemia eradication and the threshold or incremental change in transcript levels which correlate with risk of subsequent relapse.
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Assessment method [5]
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Timepoint [5]
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Measured after each treatment and 1 to 3 monthly thereafter for 2 years.
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Secondary outcome [6]
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6. To compare the utility of Q-PCR with interphase fluorescent in-situ hybridisation (i-FISH), conventional cytogenetics, and, where applicable, flow cytometry in detection of minimal residual disease and prediction of relapse risk.
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Assessment method [6]
729
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Timepoint [6]
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Measured after each treatment and 1 to 3 monthly thereafter for 2 years.
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Eligibility
Key inclusion criteria
1. A morphologic diagnosis of AML by WHO criteria; note that patients with t(8;21) and less than 20% blasts will be included.2. Confirmation of CBF subtype by cytogenetic finding of t(8;21) or inv(16) or t(16;16) (either alone or in combination with other cytogenetic abnormalities) or PCR evidence of a CBF fusion transcript 3. ECOG performance status 0 to 3; 4. Written informed consent prior to registration 5. Potentially childbearing patients must use effective contraception 6. Patients must be registered prior to the commencement of induction therapy.
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Minimum age
15
Years
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Maximum age
65
Years
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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
1. Serious cardiac or pulmonary dysfunction precluding the delivery of the proposed therapy2. Severe renal dysfunction3. Severe hepatic dysfunction including bilirubin > 2.5 ULN unless attributable to leukaemia4. Prior treatment for AML5. Contraindication to the use of study drugs6. Known HIV infection7. Pregnancy and lactation8. Inability to comply with study requirements.
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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 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
14/12/2004
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Actual
11/02/2005
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Date of last participant enrolment
Anticipated
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Actual
19/06/2009
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Date of last data collection
Anticipated
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Actual
31/12/2012
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Sample size
Target
50
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Accrual to date
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Final
53
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Leukaemia Foundation of Australia
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Address [1]
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C/- the ALLG Office, Level 2 10 St Andrews Place East Melbourne 3002
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Amgen Australia
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Address [2]
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c/- The ALLG Office, Level 2 10 St Andrews Place East Melbourne 3002
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Country [2]
331
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Australasian Leukaemia and Lymphoma Group
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Address
Level 2, 10 St Andrews Place
East Melbourne Vic 3002
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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nil
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Canberra
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Ethics committee address [1]
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N/A
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Ethics committee country [1]
1265
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Australia
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Date submitted for ethics approval [1]
1265
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Approval date [1]
1265
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Ethics approval number [1]
1265
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Ethics committee name [2]
1266
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Gosford
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Ethics committee address [2]
1266
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N/A
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Ethics committee country [2]
1266
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Australia
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Date submitted for ethics approval [2]
1266
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Approval date [2]
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12/11/2004
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Ethics approval number [2]
1266
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Ethics committee name [3]
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Hobart
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Ethics committee address [3]
1267
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N/A
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Ethics committee country [3]
1267
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Australia
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Date submitted for ethics approval [3]
1267
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Approval date [3]
1267
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Ethics approval number [3]
1267
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Ethics committee name [4]
1268
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Mater Brisbane
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Ethics committee address [4]
1268
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N/A
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Ethics committee country [4]
1268
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Australia
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Date submitted for ethics approval [4]
1268
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Approval date [4]
1268
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Ethics approval number [4]
1268
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Ethics committee name [5]
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Mater Newcastle
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Ethics committee address [5]
1269
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N/A
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Ethics committee country [5]
1269
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Australia
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Date submitted for ethics approval [5]
1269
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Approval date [5]
1269
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Ethics approval number [5]
1269
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Ethics committee name [6]
1270
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Princess Alexandra
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Ethics committee address [6]
1270
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N/A
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Ethics committee country [6]
1270
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Australia
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Date submitted for ethics approval [6]
1270
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Approval date [6]
1270
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Ethics approval number [6]
1270
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Ethics committee name [7]
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Royal Melbourne
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Ethics committee address [7]
1271
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N/A
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Ethics committee country [7]
1271
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Australia
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Date submitted for ethics approval [7]
1271
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Approval date [7]
1271
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Ethics approval number [7]
1271
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Ethics committee name [8]
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Royal Perth
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Ethics committee address [8]
1272
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N/A
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Ethics committee country [8]
1272
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Australia
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Date submitted for ethics approval [8]
1272
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Approval date [8]
1272
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Ethics approval number [8]
1272
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Ethics committee name [9]
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St Vincent's Sydney
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Ethics committee address [9]
1273
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N/A
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Ethics committee country [9]
1273
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Australia
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Date submitted for ethics approval [9]
1273
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Approval date [9]
1273
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Ethics approval number [9]
1273
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Ethics committee name [10]
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Westmead
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Ethics committee address [10]
1274
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N/A
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Ethics committee country [10]
1274
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Australia
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Date submitted for ethics approval [10]
1274
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Approval date [10]
1274
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Ethics approval number [10]
1274
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Summary
Brief summary
This trial is assessing the outcome of patients with a rare form of AML (CBF-AML) who have anthracyline (or not) as part of their treatment
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Trial website
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Trial related presentations / publications
None
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Paula Marlton
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Address
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Oncology/Haematology Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
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Country
9371
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Australia
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Phone
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+61 7 32407036
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Fax
9371
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+61 7 32402252
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Email
9371
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[email protected]
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Contact person for scientific queries
Name
299
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Dr Paula Marlton
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Address
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Oncology/Haematology Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
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Country
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Australia
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Phone
299
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+61 7 32407036
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Fax
299
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+61 7 32402252
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Email
299
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
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When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
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Available to whom?
Data are potentially available to:
• Researchers from not-for-profit organisations
• Commercial organisations
• Other
Based in:
• Any location
Further information:
All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
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Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
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How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20360
Study protocol
[email protected]
Access can be requested via the Health Data Austra...
[
More Details
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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.
Download to PDF