Trial purpose
Cancer treatment
Tumor type
Haematological
Age
40 - 65
Clinical summary
Summary
All trial participants will receive the same therapy protocol. This involves a 15-day debulking treatment with oral and/or intravenous vincristine followed by eight 28-day cycles alternating between intravenous blinatumomab therapy and intravenous methotrexate, methylprednisolone and cytarabine. After completing these alternating cycles, maintenance treatment will continue in 28-day cycles for 24 months with a combination of intravenous vincristine and oral prednisolone, mercaptopurine and methotrexate.
Conditions
This trial is treating people with Acute Lymphoblastic Leukaemia
Eligibility
Inclusion
1. Age 40 to 65 (inclusive)
2. Newly diagnosed B-precursor acute lymphoblastic leukaemia without Ph positive disease
3. CD19 positive diseases
4. Provision of informed consent for this study
5. Patient has a life-expectancy from non-leukaemia related causes ofgreater than 3 months
6. ECOG performance status of 0 to 2 inclusive
7. Absence of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine of less than 1.5 times the institutional upper limit of normal (ULN) and serum bilirubin less than 2.5 times ULN is required
8. Normal left ventricular ejection fraction, as per local institutional standards
9. No contraindication for use of study drugs
Exclusion
1. A history of major medication non-compliance
2. Evidence of known active central nervous system (CNS) leukaemia
3. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis, with the exception of history of CNS leukaemia that is controlled with intrathecal therapy
4. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
5. Pregnant or lactating
6. Women of child-bearing potential who are not willing to use 2 highly effective methods of contraception while receiving study therapy and for 3 months after completion
7. Men who are not willing to use 2 highly effective methods of contraception while receiving study therapy and for 3 months after completion
8. Men who have a pregnant partner and are not willing to use a condom while performing sexual activity or for 3 months after completion of study therapy
9. Subjects with a known sensitivity to immunoglobulins or other components of the investigational product
10. Previous diagnosis of cancer within 5 years of current diagnosis except successfully treated Basal Cell Carcinoma, Squamous Cell Carcinoma or carcinoma in situ of the cervix
11. HIV positive
12. Significant active liver disease or active Hepatitis C Virus (HCV; RNA polymerase chain reaction [PCR]-positive) or active Hepatitis B Virus (HBV; DNA PCR-positive) infection. Only patients who are HBV surface antigen (HBVsAg) and/or HBV core antibody (HBVcAb) positive are required to undergo HBV DNA PCR testing. Subjects with PCR-negative HBV or who are HBV core antibody positive are permitted in the study but must be on HBV prophylaxis.
13. Presence of New York Heart Association stage 2 or higher cardiac symptoms not related to the disease under study
14. Significant concomitant illnesses which would in the investigator’s opinion not make the patient a good candidate for the trial
15. Any other form of known condition or behaviour that deems the patient a poor candidate
16. Subjects who have been vaccinated with live virus vaccines less than 2 weeks prior to registration.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
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
Australasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
A phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia
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