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Trial registered on ANZCTR
Registration number
ACTRN12618001734257p
Ethics application status
Not yet submitted
Date submitted
17/10/2018
Date registered
22/10/2018
Date last updated
22/10/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
ALL09 - SUbstitute BLinatumomab to Improve Minimal Residual Disease Eradication in Adolescents and Young Adults with Acute Lymphoblastic Leukaemia – The SUBLIME Study
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Scientific title
ALL09 - Phase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia
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Secondary ID [1]
296359
0
ALL09
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukaemia
310087
0
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Condition category
Condition code
Cancer
308835
308835
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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
blinatumomab 28mcg/m^2 administered intravenously via an ambulatory infusion device. Dose is administered continuously, as the infusion device is taken home with the patient. The patient will require minimal instruction on the use of the infusion device, as it is programmed and monitored by the nursing staff. Digital data is captured to track dose compliance in the ambulatory setting. Blinatumomab is administered continuously over 2 x 28 day cycles, first during induction and second during the consolidation treatment, representing a 2 month gap between blinatumomab cycles. Standard of care treatment is provided outside of these 2 28-day cycles. Standard of care in this trial is the approved BFM-2000 adapted pediatric protocol currently used in centres in Australia.
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Intervention code [1]
312689
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
307805
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To assess the rate of minimal residual disease (MRD) negativity, where MRD negativity is defined as no presence of leukaemic blasts in blood or bone marrow sample as determined by EuroMRD accredited q-pcr analysis
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Timepoint [1]
307805
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day 79 of therapy
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Secondary outcome [1]
352981
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Rates of Disease Free Survival measured from the date on which remission (defined by National Comprehensive Cancer Network guidelines) is first documented until the date of relapse (defined by NCCN guidelines) or the date of death, for those patients who die in remission.
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Timepoint [1]
352981
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Time of relapse, death or censor date (minimum 2 years follow up from end of treatment)
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Eligibility
Key inclusion criteria
1. A morphological diagnosis of B-lineage ALL by WHO criteria. All clinico-pathological sub-types will be eligible, except for mature B or Burkitt ALL;
2. Bone marrow blast count greater than or equal to 20%;
3. Adequate renal and hepatic function at Screening as defined by:
a. Total bilirubin less than 2.5 x ULN unless medically correctable
b. Serum creatinine less than or equal to 200 micromol/L unless medically correctable
4. Normal left ventricular ejection fraction, according to institutional criteria;
5. An ECOG performance status score of 0-3 at Screening.
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Minimum age
15
Years
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Maximum age
40
Years
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. A diagnosis of T-lineage ALL by WHO criteria.
2. Patients known to have Philadelphia chromosome-positive disease;
3. Subjects aged less than 15 or more than 40 years at Screening;
4. Presence of serious cardiac, pulmonary, hepatic or renal disease;
5. Previous treatment for ALL or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localised cancer treated by surgical excision only more than 5 years earlier without evidence of recurrence in the intervening period).
6. Positive for HIV, or evidence of uncontrolled Hepatitis B or C infection
7. Severe active infection
8. Women who are pregnant at the time of diagnosis will not be excluded from the trial per se. A management plan will be devised between patient, obstetrician and haematologist.
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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)
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/03/2019
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Actual
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Date of last participant enrolment
Anticipated
1/03/2022
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Actual
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Date of last data collection
Anticipated
1/10/2026
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Actual
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Sample size
Target
53
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
300961
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Charities/Societies/Foundations
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Name [1]
300961
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CanTeen Australia
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Address [1]
300961
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161 Flemington Road, Melbourne VIC 3000
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Country [1]
300961
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Australia
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Funding source category [2]
300962
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Commercial sector/Industry
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Name [2]
300962
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Amgen
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Address [2]
300962
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115 Cotham Rd, Kew VIC 3101
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Country [2]
300962
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Australasian Leukaemia and Lymphoma Group
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Address
35 Elizabeth St, Richmond VIC, 3121
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Country
Australia
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Secondary sponsor category [1]
300535
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None
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Name [1]
300535
0
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Address [1]
300535
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Country [1]
300535
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
301726
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Central Adelaide Local Health Network Human Research Ethics Committee
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Ethics committee address [1]
301726
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Level 3, Roma Mitchell House
North Terrace, Adelaide SA
Australia 5000
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Ethics committee country [1]
301726
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Australia
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Date submitted for ethics approval [1]
301726
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22/10/2018
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Approval date [1]
301726
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Ethics approval number [1]
301726
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Summary
Brief summary
The purpose of this study is to determine if a new immune based therapy (called Blinatumomab) can help improve outcomes for patients with Acute Lymphoblastic Leukaemia.
Who is it for?
You may be eligible for this study if you are aged 15-40 and have been diagnosed with B-lineage Acute Lymphoblastic Leukaemia.
Study details
All participants in this study will be provided with Blinatumomab, that will be provided continuously through the vein over two cycles of 28 days using an infusion device. Participants will be provided with usual care outside of these two cycles.
79 days after commencing cycle 1, participants will need to take a blood test and a bone marrow sample will be collected.
Blood and bone marrow samples will also be taken throughout the treatment period, however these are the same as you would have taken during standard treatment outside of the trial.
It is hoped that this study will help to better understand how to successfully incorporate immune based therapy in adolescents and young adults with Acute Lymphoblastic Leukaemia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
87902
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Dr Matthew Greenwood
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Address
87902
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Department of Haematology, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
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Country
87902
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Australia
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Phone
87902
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+61 2 9926 7118
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Fax
87902
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Email
87902
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matthew.greenwood@health.nsw.gov.au
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Contact person for public queries
Name
87903
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Dr Matthew Greenwood
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Address
87903
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Department of Haematology, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
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Country
87903
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Australia
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Phone
87903
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+61 2 9926 7118
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Fax
87903
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Email
87903
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matthew.greenwood@health.nsw.gov.au
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Contact person for scientific queries
Name
87904
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Dr Matthew Greenwood
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Address
87904
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Department of Haematology, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
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Country
87904
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Australia
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Phone
87904
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+61 2 9926 7118
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Fax
87904
0
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Email
87904
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matthew.greenwood@health.nsw.gov.au
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No data has been provided for results reporting
Summary results
Not applicable
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