Trial purpose
Cancer treatment
Tumor type
Haematological
Age
15 - 40
Clinical summary
Summary
Eligible patients will receive continuous intravenous Blinatumomab over two 28-day cycles, using an infusion device that will be programmed and monitored by the nursing staff.
Conditions
This trial is treating people with acute lymphoblastic leukaemia
Eligibility
Inclusion
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
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.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
CanTeen Australia
Scientific Title
Phase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia
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