BLAM- A phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia - ALL08

Funding

Other Collaborative groups,Australasian Leukaemia and Lymphoma Group

Scientific enquiries

Dr Shaun Fleming

Brief Summary

The primary purpose of this trial is to evaluate the safety and efficacy of a Blinatumomab, Cytarabine (AraC) and Methotrexate therapy protocol for the treatment of acute lymphoblastic leukaemia. Who is it for? You may be eligible to enroll in this trial if you are aged 40 to 65 years, and have been newly diagnosed with B-precursor acute lymphoblastic leukaemia without Ph positive disease. Study details All participants enrolled in this trial will receive the same therapy protocol. This involves .... The primary purpose of this trial is to evaluate the safety and efficacy of a Blinatumomab, Cytarabine (AraC) and Methotrexate therapy protocol for the treatment of acute lymphoblastic leukaemia. Who is it for? You may be eligible to enroll in this trial if you are aged 40 to 65 years, and have been newly diagnosed with B-precursor acute lymphoblastic leukaemia without Ph positive disease. Study details All participants enrolled in this trial 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. Participants will be asked to complete questionnaires regarding their quality of life and will undergo assessments for disease progression, side effects and survival for 5 years.
Read more

Key Inclusion Criteria

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 bilir .... 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
Read more

Key Exclusion Criteria

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 autoim .... 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.
Read more