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Trial registered on ANZCTR


Registration number
ACTRN12615000631505
Ethics application status
Approved
Date submitted
19/05/2015
Date registered
17/06/2015
Date last updated
17/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II study of induction therapy using idarubicin and infusional high-dose cytarabine for adult patients with de novo untreated acute lymphoblastic leukaemia
Scientific title
A phase II study to evaluate the effect of induction therapy using idarubicin and infusional high-dose cytarabine on mortality rate and haematological toxicity in adult patients with de novo untreated acute lymphoblastic leukaemia
Secondary ID [1] 286754 0
ALLG ALL3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute lymphoblastic leukaemia 295112 0
Condition category
Condition code
Cancer 295362 295362 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Induction chemotherapy (1x 28 day cycle)
a. Cytarabine given as a 2 hour intravenous infusion at a dose of 3 gm/ m2 on day 1, followed by a continuous intravenous infusion beginning 12 hours after commencement of the initial dose for a total of 96 hours at a dose of 1.5 gm/m2 per 24 hours.
b. Idarubicin, given as an intravenous bolus at a dose of 12 mg/m2 on days 1, 2, and 3.
Supportive treatment consisting of Allopurinol 300 mg daily per oral given from day –2 until the white cell count is below 1.0 x 10^9/L, and Fluconazole 200 mg daily orally for 28 days as fungal infection prophylaxis. Filgrastim started on day + 6 at a dose of 5 microgram / kg daily by subcutaneous injection until the post-nadir neutrophil count exceeds 2.0 x 10^9/L.
One intrathecal injection of Methotrexate 12 mg given at the start of induction therapy. Induction therapy is 1x 28 day cycle.
2. Post-induction treatment (consolidation 1x 28 day cycle)
a. Cytarabine 3 gm/ m2 as an intravenous infusion over 2 hours, followed 12 hours later by a continuous intravenous infusion at a dose of 1.5 gm/m2 per 24 hours for 72 hours.
b. Idarubicin, as an intravenous bolus at a dose of 12 mg/ m2 daily on days 1 and 2.
Filgrastim from day +5 at a dose of 5 microgram per kg subcutaneously daily until recovery of the neutrophil count to greater than 2.0 x 10^9/L.
One injection of intrathecal Methotrexate 12mg given at the start of consolidation therapy.
The duration between induction and consolidation is 28 to 35 days.
Following consolidation with cytarabine and Idarubicin, a further course of therapy was given using high dose intravenous Methotrexate, as soon as practical after day 28 from the start of consolidation therapy. This consists of 3 g/m2 for 2 courses 14 days apart.
Intervention code [1] 291907 0
Treatment: Drugs
Comparator / control treatment
No comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295104 0
Induction death rate as measured by the percentage of patients dying
Timepoint [1] 295104 0
4 weeks after commencing induction therapy
Primary outcome [2] 295105 0
Incidence of grade 3 and 4 non-haematological toxicities according to the National Cancer Institute Common Terminology Criteria for Adverse Event Reporting vs 2
Timepoint [2] 295105 0
4 weeks after commencing induction therapy
Secondary outcome [1] 314781 0
Levels of residual disease using PCR-amplification of immunoglobulin gene rearrangements
Timepoint [1] 314781 0
Days 14 and 28 after induction and after consolidation therapy
Secondary outcome [2] 314782 0
Complete remission rate defined as patients meeting all the following criteria:
1. Absence of symptoms and signs of leukaemia.
2. Neutrophil count > 1.0 x 10^9/ L at least 5 days after ceasing filgrastim.
3. Platelet count greater than 100 x 10^9/ L
4. Absence of leukaemic cells in the peripheral blood
5. Normocellular bone marrow with active haemopoiesis and less than 5 % blasts.
Timepoint [2] 314782 0
After induction therapy
Secondary outcome [3] 314783 0
Leukaemia-free survival
Timepoint [3] 314783 0
One and two years following induction therapy

Eligibility
Key inclusion criteria
1. A diagnosis of acute lymphoblastic leukaemia by WHO criteria.
2. No prior therapy for ALL
3. Age 20 to 55 years inclusive.
4. Morphological subtypes FAB L1 and L2.
5. Precursor-B immunophenotype, including pre-B (cytoplasmic mu chain expression), and cases with myeloid antigen expression.
6. ECOG performance status 0 to 3 inclusive.
7. Adequate renal (serum creatinine < 150 micromols/L), hepatic (serum bilirubin <2 times upper limit of normal), and cardiac function (normal left ventricular ejection fraction as assessed according to institutional practice).
8. Not known to be seropositive for HIV.
9. Written informed consent to participate in the study.
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Precursor T or mature B (surface Ig positive) phenotypes
2. Morphological subtype FAB L3
3. Cases which are known to be Philadelphia chromosome positive, or have detectable bcr-abl transcripts by RT-PCR.
4. Past history of cancer, other than non-melanoma skin cancer or carcinoma of cervix in situ.
5. Past history of serious cardiac, pulmonary, hepatic or renal disease.
6. Pregnancy or planned continued breast feeding.

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
Actual
8/06/2002
Date of last participant enrolment
Anticipated
Actual
24/03/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 291295 0
Commercial sector/Industry
Name [1] 291295 0
Amgen Australia, Pty Ltd
Country [1] 291295 0
Australia
Funding source category [2] 291296 0
Commercial sector/Industry
Name [2] 291296 0
Pfizer Australia
Country [2] 291296 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Ground Floor, 35 Elizabeth Street, Richmond, VIC 3121
Country
Australia
Secondary sponsor category [1] 289972 0
None
Name [1] 289972 0
Address [1] 289972 0
Country [1] 289972 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292863 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 292863 0
St Andrews Place, East Melbourne, Vic 3002
Ethics committee country [1] 292863 0
Australia
Date submitted for ethics approval [1] 292863 0
Approval date [1] 292863 0
23/04/2002
Ethics approval number [1] 292863 0

Summary
Brief summary
The primary hypothesis is that an intensive chemotherapy protocol, incorporating high-dose cytarabine and Idarubicin, as originally designed for treatment of Acute Myeloid Leukaemia, when used in the treatment of adults with Acute Lymphoblastic Leukaemia, has acceptable tolerability and safety. The subsidiary hypothesis is that this regimen will result in a greater degree of reduction of the number of leukaemia cells, than conventional treatment.
Trial website
Trial related presentations / publications
There are not as yet any presentations or publications from this trial.
Public notes

Contacts
Principal investigator
Name 57406 0
Prof Ken Bradstock
Address 57406 0
Westmead Hospital,
Cnr Hawkesbury Road and Darcy Road, Westmead NSW 2145
Country 57406 0
Australia
Phone 57406 0
+612-9845 7073
Fax 57406 0
Email 57406 0
[email protected]
Contact person for public queries
Name 57407 0
Janey Stone
Address 57407 0
ALLG, Ground Floor, 35 Elizabeth Street, Richmond, VIC 3121
Country 57407 0
Australia
Phone 57407 0
+61383739706
Fax 57407 0
Email 57407 0
[email protected]
Contact person for scientific queries
Name 57408 0
Ken Bradstock
Address 57408 0
Westmead Hospital
Cnr Hawkesbury Road and Darcy Road, Westmead NSW 2145
Country 57408 0
Australia
Phone 57408 0
+612-9845 7073
Fax 57408 0
Email 57408 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
SourceTitleYear of PublicationDOI
EmbaseEffects of intensive induction and consolidation chemotherapy with idarubicin and high dose cytarabine on minimal residual disease levels in newly diagnosed adult precursor-B acute lymphoblastic leukemia.2016https://dx.doi.org/10.1016/j.conctc.2016.06.004
N.B. These documents automatically identified may not have been verified by the study sponsor.