Last updated on February 2018

MabionCD20 Compared to MabThera in Lymphoma Patients

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02617485

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University Clinical Center Banja Luka

Banja Luka, Bosnia and Herzegovina
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University Clinical Center Sarajevo

Sarajevo, Bosnia and Herzegovina
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University Clinical Center Tuzla

Tuzla, Bosnia and Herzegovina
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General Hospital Zenica

Zenica, Bosnia and Herzegovina
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GH "dr.Josip Bencevic"

Slavonski Brod, Croatia
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CH Merkur

Zagreb, Croatia
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CHC Zagreb

Zagreb, Croatia
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Tibilisi, Georgia
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Recruitment Status: Open

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