BLAM- A phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia
- Conditions
- newly diagnosed acute lymphoblastic leukaemiaCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12617000084381
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event free status. Events include death from any cause, refractory disease (failure to achieve complete response at the end of Blinatumomab cycle 2A), progressive disease, relapsed disease , off protocol for any reason (other than ASCT), or deemed lost to follow-up[ 2 years from date of registration]
- Secondary Outcome Measures
Name Time Method