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Trial registered on ANZCTR


Trial ID
ACTRN12605000095662
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
5/08/2005
Date last updated
3/06/2011
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
Gender
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 253 0
Commercial sector/Industry
Name [1] 253 0
Amgen Australia
Address [1] 253 0
-
Country [1] 253 0
Australia
Funding source category [2] 254 0
Commercial sector/Industry
Name [2] 254 0
Pfizer
Address [2] 254 0
-
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 Adlult Hospital Brisbane
Ethics committee address [1] 1061 0
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
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
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
Ethics committee country [4] 1064 0
Australia
Date submitted for ethics approval [4] 1064 0
Approval date [4] 1064 0
Ethics approval number [4] 1064 0
Ethics committee name [5] 1065 0
Box Hill Hospital
Ethics committee address [5] 1065 0
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
Ethics committee country [6] 1066 0
Australia
Date submitted for ethics approval [6] 1066 0
Approval date [6] 1066 0
Ethics approval number [6] 1066 0
Ethics committee name [7] 1067 0
Royal North Shore Hospital
Ethics committee address [7] 1067 0
Ethics committee country [7] 1067 0
Australia
Date submitted for ethics approval [7] 1067 0
Approval date [7] 1067 0
Ethics approval number [7] 1067 0
Ethics committee name [8] 1068 0
Royal Perth Hospital
Ethics committee address [8] 1068 0
Ethics committee country [8] 1068 0
Australia
Date submitted for ethics approval [8] 1068 0
Approval date [8] 1068 0
Ethics approval number [8] 1068 0
Ethics committee name [9] 1069 0
Wollongong Hospital
Ethics committee address [9] 1069 0
Ethics committee country [9] 1069 0
Australia
Date submitted for ethics approval [9] 1069 0
Approval date [9] 1069 0
Ethics approval number [9] 1069 0
Ethics committee name [10] 1070 0
Mater Hospital Newcastle
Ethics committee address [10] 1070 0
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
Ethics committee country [11] 1071 0
Australia
Date submitted for ethics approval [11] 1071 0
Approval date [11] 1071 0
Ethics approval number [11] 1071 0
Ethics committee name [12] 1072 0
Fremantle Hospital
Ethics committee address [12] 1072 0
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
Ethics committee country [13] 1073 0
Australia
Date submitted for ethics approval [13] 1073 0
Approval date [13] 1073 0
Ethics approval number [13] 1073 0
Ethics committee name [14] 1074 0
Gosford Hospital
Ethics committee address [14] 1074 0
Ethics committee country [14] 1074 0
Australia
Date submitted for ethics approval [14] 1074 0
Approval date [14] 1074 0
Ethics approval number [14] 1074 0
Ethics committee name [15] 1075 0
Geelong Hospital
Ethics committee address [15] 1075 0
Ethics committee country [15] 1075 0
Australia
Date submitted for ethics approval [15] 1075 0
Approval date [15] 1075 0
Ethics approval number [15] 1075 0
Ethics committee name [16] 1076 0
Royal Adelaide Hospital
Ethics committee address [16] 1076 0
Ethics committee country [16] 1076 0
Australia
Date submitted for ethics approval [16] 1076 0
Approval date [16] 1076 0
Ethics approval number [16] 1076 0
Ethics committee name [17] 1077 0
Canberra Hospital
Ethics committee address [17] 1077 0
Ethics committee country [17] 1077 0
Australia
Date submitted for ethics approval [17] 1077 0
Approval date [17] 1077 0
Ethics approval number [17] 1077 0
Ethics committee name [18] 1078 0
Princess Alexandra Hospital
Ethics committee address [18] 1078 0
Ethics committee country [18] 1078 0
Australia
Date submitted for ethics approval [18] 1078 0
Approval date [18] 1078 0
Ethics approval number [18] 1078 0
Ethics committee name [19] 1079 0
Royal Melbourne Hospital
Ethics committee address [19] 1079 0
Ethics committee country [19] 1079 0
Australia
Date submitted for ethics approval [19] 1079 0
Approval date [19] 1079 0
Ethics approval number [19] 1079 0
Ethics committee name [20] 1080 0
Westmead Hospital
Ethics committee address [20] 1080 0
Ethics committee country [20] 1080 0
Australia
Date submitted for ethics approval [20] 1080 0
Approval date [20] 1080 0
Ethics approval number [20] 1080 0
Ethics committee name [21] 1081 0
Peter MacCallum Cancer Centre
Ethics committee address [21] 1081 0
Ethics committee country [21] 1081 0
Australia
Date submitted for ethics approval [21] 1081 0
Approval date [21] 1081 0
Ethics approval number [21] 1081 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35325 0
Address 35325 0
Country 35325 0
Phone 35325 0
Fax 35325 0
Email 35325 0
Contact person for public queries
Name 9289 0
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
emailbradstok@icpmr.wsahs.nsw.gov.au
Contact person for scientific queries
Name 217 0
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
emailbradstok@icpmr.wsahs.nsw.gov.au