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

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

- ALL8 is a phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia. - The overall number of participants planned was 30 patients with newly diagnosed B-precursor Acute Lymphoblastic Leukaemia excluding Ph+ve. - Overall, the trial recruited 30 out of 30 patients. - The study included 22 male and 11 female patients, 40-65 years of age. - This study analysis aimed at identifying the factors involved in ALL in older adults along with factors correlating with response to combination immunotherapy and chemotherapy approaches will be performed. Data types - Data set included 30 patients. - Disease response collected as per NCCN 2015. - Quality of life (FACT-Leu v4) was collected. - Follow up data collected every 3months. - ECOS performance status was assessed for all 30 patients throughout the study until follow up. - 1 interim analysis was conducted on 31-July-2021. The analysis was performed when the first 10 patients registered on the study have been followed for at least 2 years or have experienced an event before being on study for 2 years. - Primary end point analysis is underway which is event-free status at 2 years from registration. -Cancer Australia demographic data Year of birth Aboriginal or Torres Strait Islander status (or Ethnicity)
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Chemotherapy |

Source Study




Phase 2


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 ....
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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 ....
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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 ....
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Can healthy volunteers participate?




Sample Size    30

Min. age    40 Years

Max. age    65 Years

Sex    Both males and females

Condition category    newly diagnosed acute lymphoblastic leukaemia

Condition code    Cancer


Intervention code Treatment: Drugs

Prephase 15 day debulking therapy consisting of 10mg/m^2/day vincristine days 1-4 and days 11-14 IV or oral (at the discretion of treating oncologist), 2mg/day IV vincristine day 1 and day 11, cyclohosphamide 150mg.m^2 twice daily IV day 1 to day 3. A cycle: Blinatumomab 28 micrograms per day continuous iv infusion for alternative 28 day cycles B cycle: Methylprednisolone 50mg/day twice daily oral day 1 to day 3, methotrexate 200mg/m^2 IV 2 hour continuous infusion on day 1, methotrexate 800mg/m ....
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Control group Uncontrolled

single arm study


Outcome: 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
Timepoint: 2 years from date of registration

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see