To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
Status:
Completed
Trial end date:
2018-12-29
Target enrollment:
Participant gender:
Summary
This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double
blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate
equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of
CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients
with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.