Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000095662
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
5/08/2005
Date last updated
17/07/2023
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
24/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australasian Leukaemia and Lymphoma Group Acute Myeloid Leukaemia Trial 12 (ALLG M12)
Scientific title
A randomised trial of idarubicin dose escalation in consolidation therapy following intensive induction chemotherapy incorporating high dose cytarabine in patients with untreated adult acute myeloid leukaemia, to evaluate safety and improve remission rate.
Secondary ID [1] 104 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG AMLM12
Universal Trial Number (UTN)
Trial acronym
ALLG AMLM12
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myeloid leukaemia 176 0
Condition category
Condition code
Cancer 198 198 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of two dose levels of Idarubicin in the consolidation phase of chemotherapy for AML. All patients receive the same induction therapy with Idarubicin, high dose cytarabine, and etoposide. Complete responders are then randomised, and receive 2 courses of consolidation therapy with conventional dose cytarabine, etoposide, and Idarubicin at either standard dosage (9mg per square metre daily for 2 days) or in the experimental arm 9mg per square metre daily for 3 days.
Intervention code [1] 100 0
Treatment: Drugs
Comparator / control treatment
-
Control group
Active

Outcomes
Primary outcome [1] 239 0
To study the effects of dose escalation of the anthracycline Idarubicin in consolidation treatment, following induction therapy incorporating high dose Cytarabine, on the rate of leukaemia â¿¿free survival at 3 years in younger patients with newly diagnosed de novo AML.
Timepoint [1] 239 0
At 3 years.
Secondary outcome [1] 538 0
To document the toxicity and overall survival.
Timepoint [1] 538 0
At 3 years of this treatment approach.
Secondary outcome [2] 539 0
To evaluate the effects of the investigational treatment on quality of life.
Timepoint [2] 539 0
-

Eligibility
Key inclusion criteria
1. A morphological diagnosis of AML by WHO criteria, confirmed by special stains, immunophenotyping and cytogenetics. All clinico-pathological subtypes will be eligible, except for AML with t(15;17) or variants, or core-binding factor AML (t(8;21) or inv16 or variants). 2. ECOG performance status 0 to 3 inclusive. 3. Absence of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine <200 mmol/L and serum bilirubin < 2.5 times the upper limit of normal, unless medically correctable. 4. Normal left ventricular ejection fraction, according to institutional criteria. If the clinical circumstances require that treatment must be given urgently before this can be ascertained, the absence of clinical cardiac impairment is acceptable, provided that a normal left ventricular ejection fraction is confirmed prior to the first consolidation cycle. 5. No previous treatment for AML or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localized cancer treated by surgical excision only more than 5 years earlier without evidence of recurrence in the intervening period ). 6. No contraindication to the use of the study drugs. 7. Treatment must be given at an affiliated ALLG centre, with approval of the protocol by the institutions Human Ethics Committee, or equivalent body. 8. Written informed consent must be obtained from each patient prior to registration and start of treatment.
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated allocation in Trial Centre, arm revealed only after patient registration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2003
Actual
16/07/2003
Date of last participant enrolment
Anticipated
Actual
21/04/2010
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
325
Accrual to date
Final
442
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 253 0
Commercial sector/Industry
Name [1] 253 0
Amgen Australia
Country [1] 253 0
Australia
Funding source category [2] 254 0
Commercial sector/Industry
Name [2] 254 0
Pfizer
Country [2] 254 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
-
Country
Australia
Secondary sponsor category [1] 193 0
None
Name [1] 193 0
nil
Address [1] 193 0
Country [1] 193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1061 0
Mater Adult Hospital Brisbane
Ethics committee address [1] 1061 0
Mater Hospital Brisbane
Raymond Terrace
South Brisbane QLD 4101
Ethics committee country [1] 1061 0
Australia
Date submitted for ethics approval [1] 1061 0
Approval date [1] 1061 0
Ethics approval number [1] 1061 0
Ethics committee name [2] 1062 0
Royal Brisbane Hospital
Ethics committee address [2] 1062 0
Butterfield St, Herston QLD 4029
Ethics committee country [2] 1062 0
Australia
Date submitted for ethics approval [2] 1062 0
Approval date [2] 1062 0
Ethics approval number [2] 1062 0
Ethics committee name [3] 1063 0
St Vincent's Hospital Melbourne
Ethics committee address [3] 1063 0
41 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [3] 1063 0
Australia
Date submitted for ethics approval [3] 1063 0
Approval date [3] 1063 0
Ethics approval number [3] 1063 0
Ethics committee name [4] 1064 0
St Vincent's Hospital Sydney
Ethics committee address [4] 1064 0
390 Victoria St, Darlinghurst NSW 2010
Ethics committee country [4] 1064 0
Australia
Date submitted for ethics approval [4] 1064 0
Approval date [4] 1064 0
01/10/2004
Ethics approval number [4] 1064 0
Ethics committee name [5] 1065 0
Box Hill Hospital
Ethics committee address [5] 1065 0
8 Arnold St, Box Hill VIC 3128
Ethics committee country [5] 1065 0
Australia
Date submitted for ethics approval [5] 1065 0
Approval date [5] 1065 0
Ethics approval number [5] 1065 0
Ethics committee name [6] 1066 0
Queen Elizabeth Hospital
Ethics committee address [6] 1066 0
53 Thomas St, Noble Park VIC 3174
Ethics committee country [6] 1066 0
Australia
Date submitted for ethics approval [6] 1066 0
Approval date [6] 1066 0
29/01/2007
Ethics approval number [6] 1066 0
Ethics committee name [7] 1067 0
Royal North Shore Hospital
Ethics committee address [7] 1067 0
Reserve Rd, St Leonards NSW 2065
Ethics committee country [7] 1067 0
Australia
Date submitted for ethics approval [7] 1067 0
Approval date [7] 1067 0
20/08/2003
Ethics approval number [7] 1067 0
Ethics committee name [8] 1068 0
Royal Perth Hospital
Ethics committee address [8] 1068 0
Victoria Square, Perth WA 6000
Ethics committee country [8] 1068 0
Australia
Date submitted for ethics approval [8] 1068 0
Approval date [8] 1068 0
04/06/2003
Ethics approval number [8] 1068 0
Ethics committee name [9] 1069 0
Wollongong Hospital
Ethics committee address [9] 1069 0
Loftus St, Wollongong NSW 2500
Ethics committee country [9] 1069 0
Australia
Date submitted for ethics approval [9] 1069 0
Approval date [9] 1069 0
06/12/2004
Ethics approval number [9] 1069 0
Ethics committee name [10] 1070 0
Mater Hospital Newcastle
Ethics committee address [10] 1070 0
Edith St, Waratah NSW 2298
Ethics committee country [10] 1070 0
Australia
Date submitted for ethics approval [10] 1070 0
Approval date [10] 1070 0
Ethics approval number [10] 1070 0
Ethics committee name [11] 1071 0
Sir Charles Gairdner Hospital
Ethics committee address [11] 1071 0
Hospital Ave, Nedlands WA 6009
Ethics committee country [11] 1071 0
Australia
Date submitted for ethics approval [11] 1071 0
Approval date [11] 1071 0
24/09/2003
Ethics approval number [11] 1071 0
Ethics committee name [12] 1072 0
Fremantle Hospital
Ethics committee address [12] 1072 0
Alma St, Fremantle WA 6160
Ethics committee country [12] 1072 0
Australia
Date submitted for ethics approval [12] 1072 0
Approval date [12] 1072 0
Ethics approval number [12] 1072 0
Ethics committee name [13] 1073 0
Royal Hobart Hospital
Ethics committee address [13] 1073 0
48 Liverpool St, Hobart TAS 7000
Ethics committee country [13] 1073 0
Australia
Date submitted for ethics approval [13] 1073 0
Approval date [13] 1073 0
03/12/2003
Ethics approval number [13] 1073 0
Ethics committee name [14] 1074 0
Gosford Hospital
Ethics committee address [14] 1074 0
Holden St, Gosford NSW 2250
Ethics committee country [14] 1074 0
Australia
Date submitted for ethics approval [14] 1074 0
Approval date [14] 1074 0
25/02/2004
Ethics approval number [14] 1074 0
Ethics committee name [15] 1075 0
Geelong Hospital
Ethics committee address [15] 1075 0
Bellerine St, Geelong VIC 3220
Ethics committee country [15] 1075 0
Australia
Date submitted for ethics approval [15] 1075 0
Approval date [15] 1075 0
18/12/2003
Ethics approval number [15] 1075 0
Ethics committee name [16] 1076 0
Royal Adelaide Hospital
Ethics committee address [16] 1076 0
Port Rd, Adelaide SA 5000
Ethics committee country [16] 1076 0
Australia
Date submitted for ethics approval [16] 1076 0
Approval date [16] 1076 0
23/04/2004
Ethics approval number [16] 1076 0
Ethics committee name [17] 1077 0
Canberra Hospital
Ethics committee address [17] 1077 0
Yamba Dr, Garran ACT 2605
Ethics committee country [17] 1077 0
Australia
Date submitted for ethics approval [17] 1077 0
Approval date [17] 1077 0
28/07/2003
Ethics approval number [17] 1077 0
Ethics committee name [18] 1078 0
Princess Alexandra Hospital
Ethics committee address [18] 1078 0
199 Ipswich Rd, Woolloongabba QLD 4102
Ethics committee country [18] 1078 0
Australia
Date submitted for ethics approval [18] 1078 0
Approval date [18] 1078 0
08/07/2003
Ethics approval number [18] 1078 0
Ethics committee name [19] 1079 0
Royal Melbourne Hospital
Ethics committee address [19] 1079 0
300 Grattan St, Melbourne VIC 3000
Ethics committee country [19] 1079 0
Australia
Date submitted for ethics approval [19] 1079 0
Approval date [19] 1079 0
19/02/2004
Ethics approval number [19] 1079 0
Ethics committee name [20] 1080 0
Westmead Hospital
Ethics committee address [20] 1080 0
Cnr Hawkesbury Road and Darcy Road Westmead NSW 2145
Ethics committee country [20] 1080 0
Australia
Date submitted for ethics approval [20] 1080 0
Approval date [20] 1080 0
05/06/2006
Ethics approval number [20] 1080 0
Ethics committee name [21] 1081 0
Peter MacCallum Cancer Centre
Ethics committee address [21] 1081 0
305 Grattan St, Melbourne VIC 3000
Ethics committee country [21] 1081 0
Australia
Date submitted for ethics approval [21] 1081 0
Approval date [21] 1081 0
25/07/2003
Ethics approval number [21] 1081 0

Summary
Brief summary
Improvements in treatment results for adult acute myeloid leukaemia (AML) over the past 15 years have come mainly from the use of higher dose intensity of existing chemotherapy agents, rather than from the introduction of new classes of anti-leukaemic drugs. Increased dose intensity protocols have included the use of chemo-radiotherapy, Early intensification of treatment using the most effective drugs available for AML is a highly effective strategy, possibly through rapid elimination of potentially drug-resistant cells.

Hypothesis;
a) That Palifermin, given as three doses of 60 µg/kg per day IV before and three doses after ICE chemotherapy, will reduce the incidence of grades 3 and 4 oral mucositis.

b) That an increase in the dose intensity of Idarubicin given early during the initial treatment of AML will result in significantly greater anti-leukaemic activity, and that this dose escalation of Idarubicin in consolidation treatment following induction therapy with high dose Cytarabine will achieve improved leukaemia-free survival.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 35325 0
A/Prof Kenneth Bradstock
Address 35325 0
Haematology Department Westmead Hospital Darcy Rd Westmead NSW 2145
Country 35325 0
Australia
Phone 35325 0
+61 2 98457073
Fax 35325 0
Email 35325 0
[email protected]
Contact person for public queries
Name 9289 0
A/Prof Associate Professor Kenneth Bradstock
Address 9289 0
Haematology Department
Westmead Hospital
Darcy Rd
Westmead NSW 2145
Country 9289 0
Australia
Phone 9289 0
+61 2 98457073
Fax 9289 0
+61 2 96892331
Email 9289 0
[email protected]
Contact person for scientific queries
Name 217 0
A/Prof Associate Professor Kenneth Bradstock
Address 217 0
Haematology Department
Westmead Hospital
Darcy Rd
Westmead NSW 2145
Country 217 0
Australia
Phone 217 0
+61 2 98457073
Fax 217 0
+61 2 96892331
Email 217 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
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.
Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
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]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19714Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Idarubicin Dose Escalation During Consolidation Th... [More Details]

Documents added automatically
No additional documents have been identified.