ALL08

Australasian Leukaemia and Lymphoma Group (ALLG)

Shaun Fleming (Alfred Hospital)

Basic 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.

Australasian Leukaemia and Lymphoma Group (ALLG)

Chemotherapy

• P365: Sequential Blinatumomab with Reduced Intensity Chemotherapy for Older Adults with Newly Diagnosed Ph- B-Precursor Acute Lymphoblastic Leukemia – Final Results Of The ALLG ALL08 Study

Access can be requested via the Health Data Australia catalogue. Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to info@allg.org.au