Evaluate the Efficacy and Safety of HLX01 Versus Mabthera in Patients With Low Tumour Burden Follicular Lymphoma.
Status:
Withdrawn
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
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.