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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
Scientific title
ALL09 - Phase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia
Secondary ID [1] 296359 0
ALL09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukaemia 310087 0
Condition category
Condition code
Cancer 308835 308835 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312689 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307805 0
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
Timepoint [1] 307805 0
day 79 of therapy
Secondary outcome [1] 352981 0
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.
Timepoint [1] 352981 0
Time of relapse, death or censor date (minimum 2 years follow up from end of treatment)

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.
Minimum age
15 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300961 0
Charities/Societies/Foundations
Name [1] 300961 0
CanTeen Australia
Address [1] 300961 0
161 Flemington Road, Melbourne VIC 3000
Country [1] 300961 0
Australia
Funding source category [2] 300962 0
Commercial sector/Industry
Name [2] 300962 0
Amgen
Address [2] 300962 0
115 Cotham Rd, Kew VIC 3101
Country [2] 300962 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australasian Leukaemia and Lymphoma Group
Address
35 Elizabeth St, Richmond VIC, 3121
Country
Australia
Secondary sponsor category [1] 300535 0
None
Name [1] 300535 0
Address [1] 300535 0
Country [1] 300535 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301726 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 301726 0
Level 3, Roma Mitchell House
North Terrace, Adelaide SA
Australia 5000
Ethics committee country [1] 301726 0
Australia
Date submitted for ethics approval [1] 301726 0
22/10/2018
Approval date [1] 301726 0
Ethics approval number [1] 301726 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87902 0
Dr Matthew Greenwood
Address 87902 0
Department of Haematology, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country 87902 0
Australia
Phone 87902 0
+61 2 9926 7118
Fax 87902 0
Email 87902 0
matthew.greenwood@health.nsw.gov.au
Contact person for public queries
Name 87903 0
Dr Matthew Greenwood
Address 87903 0
Department of Haematology, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country 87903 0
Australia
Phone 87903 0
+61 2 9926 7118
Fax 87903 0
Email 87903 0
matthew.greenwood@health.nsw.gov.au
Contact person for scientific queries
Name 87904 0
Dr Matthew Greenwood
Address 87904 0
Department of Haematology, Royal North Shore Hospital
Reserve Rd, St Leonards NSW 2065
Country 87904 0
Australia
Phone 87904 0
+61 2 9926 7118
Fax 87904 0
Email 87904 0
matthew.greenwood@health.nsw.gov.au

No data has been provided for results reporting
Summary results
Not applicable