Last updated on September 2016

Safety and Efficacy Study of BCD-020 in Therapy of Non-Hodgkin's Lymphoma

Brief description of study

This international multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (NN: rituximab, CJSC Biocad) versus MabThera (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a monotherapy of patients with indolent non-Hodgkin's lymphoma. Patients will be randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for 4 weeks or MabThera at the same regimen.

Clinical Study Identifier: NCT01701232

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City Hospital N8

Barnaul, Russian Federation
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Clinical Oncology Dispensary N1

Krasnodar, Russian Federation
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Pyatigorsk Oncology Center

Pyatigorsk, Russian Federation
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Oncology Dispensary 2

Sochi, Russian Federation
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N.N.Petrov Oncology Research Center

St.Petersburg, Russian Federation
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Tula Regional Hospital

Tula, Russian Federation
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Medi-Clinic Vereeniging

Vereeniging, South Africa
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Recruitment Status: Open

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