The study is a Phase 3 multi-centre, randomised, double-blind, parallel-arm study to evaluate the efficacy and safety of HLX01 versus European Union (EU)-sourced Mabthera® as first line treatment in patients with low tumour burden FL. The study will consist of a Screening Period (up to 42 days), Treatment Period (Week 1 to Week 44/Month 11), and End of Study (EOS; Month 12 Visit). Approximately 212 patients (106 in each treatment group) will be enrolled. Utilising a 1-sided 97.5% CI for the risk difference, a reference proportion of 83.2% for Mabthera®, delta for non-inferiority of -17%, and assuming a true difference of 1%, a sample size of 106 patients per arm (212 total) provides approximately 85% power to show non-inferiority of HLX01 to Mabthera® on a primary endpoint of risk difference in ORR up to Week 28. No dropout is included, as all patients will either have data provided for ORR (based on best response), or will be classed as non-responder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Patients will receive HLX01 intravenous (IV) infusion once a week for 4 weeks induction treatment (on Days 1, 8, 15, and 22), and then continue to receive maintenance treatment at Weeks 12, 20, 28, 36, and 44.
Patients will receive Mabthera® intravenous (IV) infusion once a week for 4 weeks induction treatment (on Days 1, 8, 15, and 22), and then continue to receive maintenance treatment at Weeks 12, 20, 28, 36, and 44.
Overall Response Rate
Overall Response Rate up to Week 28, defined as the proportion of patients achieving either complete response (CR) or PR as best response from the first dose of study drug through Week 28 as assessed by a blinded independent review committee according to the Modified Lugano Response Classification 2014.
Time frame: rom the first dose of study drug through Week 28
AEs
adverse events
Time frame: up to 12 months
SAEs
serious adverse events
Time frame: up to 12 months
Immunogenicity
ADA and neutralising antibody
Time frame: up to 12 months
Time-to-progression of disease (TTPD)
Time-to-progression of disease
Time frame: up to 12 months
PFS
progression-free survival
Time frame: up to 12 months
Cmax
max blood cocentration
Time frame: up to 12 months
Ctrough
trough serum concentration after each dose during induction period and selected doses thereafter
Time frame: up to 12 months
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