Blinatumomab vs SOC GMALL in Older Adults with Newly Diagnosed ALL
Research type
Research Study
Full title
Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
IRAS ID
303325
Contact name
Adele Fielding
Contact email
Sponsor organisation
Amgen Limited
Eudract number
2020-004498-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 10 months, 10 days
Research summary
This study is trying to establish an improved treatment for older adults with newly diagnosed Philadelphia negative B-cell Precursor Acute Lymphoblastic Leukaemia (bone marrow cell cancer).
This study will determine if the experimental arm (the new therapy being tested) consisting of blinatumomab (a molecule that binds to leukaemia cells and cells of the immune system and thereby helps the immune system to destroy the leukaemia cells) combined with less intensive chemotherapy, compared with standard of care (SOC) - (GMALL Regimen), will prolong survival, duration of remission (when no leukaemia cells are present) while also decreasing toxicities that can occur with chemotherapy presently used in the SOC arm. Patients on the SOC arm will also be eligible to receive blinatumomab to treat their leukaemia if, during their treatment phase, the week 14 disease assessment shows any leukaemia cells.
All patients in this study are randomised into 1 of 2 groups (the experimental therapy-blinatumomab with low intensity chemotherapy or SOC arm). Randomised means that patients are put into a group by chance. It is like flipping a coin. They will have a 50% chance of receiving blinatumomab with low intensity chemotherapy or the SOC - (GMALL Regimen). The treatment length is approximately 2.5 years. After treatment patients will continue to be monitored for evidence of leukaemia under this study for up to approximately 5 years.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0154
Date of REC Opinion
10 May 2022
REC opinion
Further Information Favourable Opinion