Study design & results
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Trial intelligence / Profile preview
Golden Gate study of blinatumomab alternating with low-intensity chemotherapy versus standard chemotherapy in older adults with newly diagnosed Philadelphia-negative B-cell precursor acute lymphoblastic leukemia
2023-503640-14-00Phase 3Authorised
- Sponsor
- Amgen
- Start
- Apr 2024
- Modality
- T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, scFv Fragments → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
- Countries
- 26
01
Overview
Phase 3, randomised, open-label trial of blinatumomab in acute lymphoblastic leukemia (ALL) (2 arms), sponsored by Amgen. Primary endpoints: Treatment-emergent adverse events, treatment-related adverse events, and adverse events of interest, Event-free survival and 1 more. Planned start Apr 2024; status: authorised.
02
Drugs
blinatumomab
03
Conditions
acute lymphoblastic leukemia (ALL)
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