Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000410459
Ethics application status
Approved
Date submitted
3/08/2007
Date registered
13/08/2007
Date last updated
31/08/2023
Date data sharing statement initially provided
31/08/2023
Date results provided
31/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II trial in patients with acute promyelocytic leukaemia (APML) to evaluate the effects of: all-trans retinoic acid combined with intensive idarubicin during induction and consolidation; subsequent intermittent all-trans retinoic acid; and molecular monitorting for evidence of minimal residual leukaemia and for evidence of incipient relapse.
Scientific title
A phase II trial in patients with acute promyelocytic leukaemia (APML) to evaluate the effects of: all-trans retinoic acid (ATRA) combined with intensive idarubicin during induction and consolidation; subsequent intermittent all-trans retinoic acid; and molecular monitoring for evidence of minimal residual leukaemia and for evidence of incipient relapse, as measured by remission rate, relapse rate and overall survival.
Secondary ID [1] 451 0
Australasian Leukaemia and Lymphoma Group (ALLG): APML3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute promyelocytic leukaemia 2217 0
Condition category
Condition code
Cancer 2308 2308 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Induction therapy: Two cycles of intensive idarubicin 12mg /m2 intravenously (IV) on days 2, 4, 6 and 8, (9mg/m2 for age 61-70, and 6mg/m2 for age > 70), together with continuous ATRA 45mg/m2/day orally starting on day 1 and Prednisone 50mg/day orally.
Consolidation: 3 cycles of ATRA (45mg/m2/day orally) for 2 weeks out of every 4-week cycle.
Maintenance (for a total of 2 years): ATRA 45mg/m2/d orally for 15 days every 3 months plus 6-mercaptopurine (6MP) 90mg/m^2/d orally plus Methotrexate 15mg/m^2 once weekly orally.
Intervention code [1] 1928 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3203 0
1. To maximise the complete remission rate (number of patients achieving remission) by combining all-trans retinoic acid (ATRA) with intensive idarubicin chemotherapy, assessed after induction cycle 1 and after induction cycle 2.
Timepoint [1] 3203 0
Assessed after induction cycle 1 and after induction cycle 2.
Primary outcome [2] 3204 0
2. To minimise the relapse rate by employing a second course of idarubicin followed by intermittent ATRA for eradication of minimal residual leukaemia as measured by the actuarial relapse free survival (measured from date of remission to date of relapse). This is measured annually, starting from one year after closure of trial to study close-out date
Timepoint [2] 3204 0
This is measured annually, starting from one year after closure of trial to study close-out date
Primary outcome [3] 3205 0
3. To maximise overall survival (measured from day 1 to death) through an intensive program of molecular monitoring for the detection of incipient relapse, combined with an aggressive therapeutic intervention strategy aimed at eradication of low levels of recurrent leukaemia. Overall survival is measured annually, starting from one year after closure of trial to study close-out date
Timepoint [3] 3205 0
Overall survival is measured annually, starting from one year after closure of trial to study close-out date
Secondary outcome [1] 5391 0
There are no secondary outcomes.
Timepoint [1] 5391 0
Not applicable.

Eligibility
Key inclusion criteria
1. Morphological diagnosis of de novo acute promyelocytic leukaemia
2. Demonstration of PML-RAR fusion transcripts by reverse transcriptase-polymerase chain reaction (RT-PCR)
3. Eastern Cooperative Oncology Group performance status 0-3, and absence of previous history of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine >200 micro mol/L or serum bilirubin
>80µmol/L precludes entry into the study, unless medically correctable.
4. A left ventricular ejection fraction of at least 50% as demonstrated by gated heart pool scan (preferably) or by cardiac ultrasound.
5. No previous treatment for APL, or history of cancer (other than basal cell skin cancer, or carcinoma of cervix in situ).
6. No contra-indication to use of any of the study drugs.
7. Treatment will be carried out at an affiliated ALLG centre, with approval of the protocol by the Institutional Human Ethics Committee or equivalent.
8. A negative pregnancy test in females of child-bearing age.
9. Written informed consent will be given by each patient.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no specified exclusion criteria. All patients who met the inclusion criteria were eligible for the trial.

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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/1997
Actual
19/08/1997
Date of last participant enrolment
Anticipated
Actual
22/10/2002
Date of last data collection
Anticipated
Actual
31/03/2007
Sample size
Target
100
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 2474 0
Commercial sector/Industry
Name [1] 2474 0
Pharmacia
Country [1] 2474 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
C/- Peter MacCallum Cancer Centre
10 St Andrews Place
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 2247 0
None
Name [1] 2247 0
Nil.
Address [1] 2247 0
Not applicable.
Country [1] 2247 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4351 0
Royal Adelaide Hospital
Ethics committee address [1] 4351 0
Ethics committee country [1] 4351 0
Australia
Date submitted for ethics approval [1] 4351 0
Approval date [1] 4351 0
Ethics approval number [1] 4351 0
Ethics committee name [2] 4352 0
Alfred Hospital
Ethics committee address [2] 4352 0
Ethics committee country [2] 4352 0
Australia
Date submitted for ethics approval [2] 4352 0
Approval date [2] 4352 0
Ethics approval number [2] 4352 0
Ethics committee name [3] 4353 0
Auckland Hospital
Ethics committee address [3] 4353 0
Ethics committee country [3] 4353 0
New Zealand
Date submitted for ethics approval [3] 4353 0
Approval date [3] 4353 0
Ethics approval number [3] 4353 0
Ethics committee name [4] 4354 0
Austin Hospital
Ethics committee address [4] 4354 0
Ethics committee country [4] 4354 0
Australia
Date submitted for ethics approval [4] 4354 0
Approval date [4] 4354 0
Ethics approval number [4] 4354 0
Ethics committee name [5] 4355 0
Ballarat Base Hospital
Ethics committee address [5] 4355 0
Ethics committee country [5] 4355 0
Australia
Date submitted for ethics approval [5] 4355 0
Approval date [5] 4355 0
Ethics approval number [5] 4355 0
Ethics committee name [6] 4356 0
Canberra Hospital
Ethics committee address [6] 4356 0
Ethics committee country [6] 4356 0
Australia
Date submitted for ethics approval [6] 4356 0
Approval date [6] 4356 0
Ethics approval number [6] 4356 0
Ethics committee name [7] 4357 0
Fremantle Hospital
Ethics committee address [7] 4357 0
Ethics committee country [7] 4357 0
Australia
Date submitted for ethics approval [7] 4357 0
Approval date [7] 4357 0
Ethics approval number [7] 4357 0
Ethics committee name [8] 4358 0
Geelong Hospital
Ethics committee address [8] 4358 0
Ethics committee country [8] 4358 0
Australia
Date submitted for ethics approval [8] 4358 0
Approval date [8] 4358 0
Ethics approval number [8] 4358 0
Ethics committee name [9] 4359 0
Royal Hobart Hospital
Ethics committee address [9] 4359 0
Ethics committee country [9] 4359 0
Australia
Date submitted for ethics approval [9] 4359 0
Approval date [9] 4359 0
Ethics approval number [9] 4359 0
Ethics committee name [10] 4360 0
Liverpool Hospital
Ethics committee address [10] 4360 0
Ethics committee country [10] 4360 0
Australia
Date submitted for ethics approval [10] 4360 0
Approval date [10] 4360 0
Ethics approval number [10] 4360 0
Ethics committee name [11] 4361 0
Mater Private Hospital
Ethics committee address [11] 4361 0
Ethics committee country [11] 4361 0
Australia
Date submitted for ethics approval [11] 4361 0
Approval date [11] 4361 0
Ethics approval number [11] 4361 0
Ethics committee name [12] 4362 0
Mater Hospital Brisbane
Ethics committee address [12] 4362 0
Ethics committee country [12] 4362 0
Australia
Date submitted for ethics approval [12] 4362 0
Approval date [12] 4362 0
Ethics approval number [12] 4362 0
Ethics committee name [13] 4363 0
Mater Hospital Newcastle
Ethics committee address [13] 4363 0
Ethics committee country [13] 4363 0
Australia
Date submitted for ethics approval [13] 4363 0
Approval date [13] 4363 0
Ethics approval number [13] 4363 0
Ethics committee name [14] 4364 0
Monash Medical Centre
Ethics committee address [14] 4364 0
Ethics committee country [14] 4364 0
Australia
Date submitted for ethics approval [14] 4364 0
Approval date [14] 4364 0
Ethics approval number [14] 4364 0
Ethics committee name [15] 4365 0
Peter MacCallum Cancer Centre
Ethics committee address [15] 4365 0
Ethics committee country [15] 4365 0
Australia
Date submitted for ethics approval [15] 4365 0
Approval date [15] 4365 0
Ethics approval number [15] 4365 0
Ethics committee name [16] 4366 0
Princess Alexandra Hospital
Ethics committee address [16] 4366 0
Ethics committee country [16] 4366 0
Australia
Date submitted for ethics approval [16] 4366 0
Approval date [16] 4366 0
Ethics approval number [16] 4366 0
Ethics committee name [17] 4367 0
Queen Elizabeth Hospital
Ethics committee address [17] 4367 0
Ethics committee country [17] 4367 0
Australia
Date submitted for ethics approval [17] 4367 0
Approval date [17] 4367 0
Ethics approval number [17] 4367 0
Ethics committee name [18] 4368 0
Royal Melbourne Hospital
Ethics committee address [18] 4368 0
Ethics committee country [18] 4368 0
Australia
Date submitted for ethics approval [18] 4368 0
Approval date [18] 4368 0
Ethics approval number [18] 4368 0
Ethics committee name [19] 4369 0
Royal Perth Hospital
Ethics committee address [19] 4369 0
Ethics committee country [19] 4369 0
Australia
Date submitted for ethics approval [19] 4369 0
Approval date [19] 4369 0
Ethics approval number [19] 4369 0
Ethics committee name [20] 4370 0
Royal Prince Alfred Hospital
Ethics committee address [20] 4370 0
Ethics committee country [20] 4370 0
Australia
Date submitted for ethics approval [20] 4370 0
Approval date [20] 4370 0
Ethics approval number [20] 4370 0
Ethics committee name [21] 4371 0
St George Hospital
Ethics committee address [21] 4371 0
Ethics committee country [21] 4371 0
Australia
Date submitted for ethics approval [21] 4371 0
Approval date [21] 4371 0
Ethics approval number [21] 4371 0
Ethics committee name [22] 4372 0
St Vincent's Hospital Sydney
Ethics committee address [22] 4372 0
Ethics committee country [22] 4372 0
Australia
Date submitted for ethics approval [22] 4372 0
Approval date [22] 4372 0
Ethics approval number [22] 4372 0
Ethics committee name [23] 4373 0
Townsville Hospital
Ethics committee address [23] 4373 0
Ethics committee country [23] 4373 0
Australia
Date submitted for ethics approval [23] 4373 0
Approval date [23] 4373 0
Ethics approval number [23] 4373 0
Ethics committee name [24] 4374 0
Wesley Medical Centre
Ethics committee address [24] 4374 0
Ethics committee country [24] 4374 0
Australia
Date submitted for ethics approval [24] 4374 0
Approval date [24] 4374 0
Ethics approval number [24] 4374 0
Ethics committee name [25] 4375 0
Westmead Hospital
Ethics committee address [25] 4375 0
Ethics committee country [25] 4375 0
Australia
Date submitted for ethics approval [25] 4375 0
Approval date [25] 4375 0
Ethics approval number [25] 4375 0
Ethics committee name [26] 4376 0
Woolongong Hospital
Ethics committee address [26] 4376 0
Ethics committee country [26] 4376 0
Australia
Date submitted for ethics approval [26] 4376 0
Approval date [26] 4376 0
Ethics approval number [26] 4376 0

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

Contacts
Principal investigator
Name 27742 0
A/Prof Harry Iland
Address 27742 0
Institute of Haematology Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
Country 27742 0
Australia
Phone 27742 0
+61 2 95157451
Fax 27742 0
Email 27742 0
[email protected]
Contact person for public queries
Name 11117 0
A/Prof Harry Iland
Address 11117 0
Institute of Haematology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 11117 0
Australia
Phone 11117 0
+61 2 95157451
Fax 11117 0
+61 2 95156698
Email 11117 0
[email protected]
Contact person for scientific queries
Name 2045 0
A/Prof Harry Iland
Address 2045 0
Institute of Haematology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 2045 0
Australia
Phone 2045 0
+61 2 95157451
Fax 2045 0
+61 2 95156698
Email 2045 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 sponsor ALLG 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. Proposals will be 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
20192Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]



Results publications and other study-related documents

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