None listed
Conditions
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.
Interventions
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 c
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.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 40 Years
Healthy volunteers
No
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.
Exclusion criteria
1. A diagnosis of T-lineage ALL by WHO criteria. 2. Patients known to have Philadelphia chromosome positive disease as defined by WHO criteria using standard karyotype and/or fluorescence in situ hybridization (FISH) analysis and/or BCR-ABL1 fusion transcript detection 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.
Outcome results
None listed