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Clinical Trial Summary

The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.


Clinical Trial Description

Patients who meet criteria for participation in this study receive 8 intravenous infusions of MabionCD20® or MabThera® 21 days interval in combination with standard dosage regimen of CHOP. The duration of the study is 12 months. The treatment and observation period will last 26 weeks starting from Day 1, until Week 26 - one month after last IMP infusion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02617485
Study type Interventional
Source Mabion SA
Contact
Status Completed
Phase Phase 3
Start date December 2015
Completion date January 2018

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