This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (JS203-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.
A Randomized Open-Label Multicenter Phase III Clinical Trial Comparing JS203 Combined With gemcitabine plus oxaliplatin (JS203-GemOx) Versus rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
282
gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W for up to 1 year
Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Overall survival (OS)
Overall survival (OS) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 24 months
Objective response rate (ORR)
Objective response rate (ORR) based on 2014 Lugano criteria
Time frame: up to approximately 12 months
complete response (CR)
The complete response rate (CR) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 12 months
Duration of response (DoR)
Duration of response (DoR) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 12 months
Duration of complete response (DoCR)
Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 12 months
Adverse events (AE)
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
Time frame: up to approximately 15 months
PK
The serum drug concentration of JS203
Time frame: up to approximately 15 months
ADA
The incidence and titer of the anti-drug antibody (ADA) of JS203
Time frame: up to approximately 15 months
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NAb
The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)
Time frame: up to approximately 15 months