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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Andrey Biryulin, MD

Brest Oncology Center
Brest, Belarus
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Andrey Biryulin, MD

Gomel Oncology Center
Gomel, Belarus
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Andrey Biryulin, MD

Grodno Regional Hospital
Grodno, Belarus
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Andrey Biryulin, MD

Vitebsk Medical State University
Vitebsk, Belarus
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Andrey Biryulin, MD

Trymed Biocancer Centro de Pesquisa Cl nica SA
Belo Horizonte, Brazil
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Andrey Biryulin, MD

Hospital de Cl nicas Universidade Federal do Paran
Curitiba, Brazil
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Andrey Biryulin, MD

Centro de Novos Tratamentos Itaja - Cl nica de Neoplasias Litoral
Itajaí, Brazil
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Andrey Biryulin, MD

Funda o Hospital Amaral Carvalho
Jaú, Brazil
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Andrey Biryulin, MD

PRO ONCO Centro de Tratamento Ontol gico SC LTDA
Londrina, Brazil
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Andrey Biryulin, MD

Hospital da Cidade de Passo Fundo
Passo Fundo, Brazil
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Andrey Biryulin, MD

Hospital S o Lucas - PUC Porto Alegre
Porto Alegre, Brazil
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Andrey Biryulin, MD

Hospital Nossa Senhora da Concei o S.A.
Porto Alegre, Brazil
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Andrey Biryulin, MD

Funda o Faculdade Regional de Medicina de S o Jos do Rio Preto
São José do Rio Preto, Brazil
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Andrey Biryulin, MD

Cl nica de Oncologia M dica
São Paulo, Brazil
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Andrey Biryulin, MD

Funda o Antonio Prudente - Hospital AC Camargo
São Paulo, Brazil
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Andrey Biryulin, MD

Hospital do Servidor P blico Estadual - FMO
São Paulo, Brazil
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Andrey Biryulin, MD

Instituto Nacional de Cancerolog a
Bogotá, Colombia
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Andrey Biryulin, MD

Fundaci n Reina Isabel
Cali, Colombia
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Andrey Biryulin, MD

Hospital Pablo Tobon Uribe
Medellín, Colombia
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Andrey Biryulin, MD

HCG Multi Specialty Hospitals
Ahmedabad, India
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Andrey Biryulin, MD

Department of Medical Oncology, Navneet Memorial Hospital, "Sushrusha"
Ahmedabad, India
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Andrey Biryulin, MD

HCG Bangalore Institute of Oncology
Bangalore, India
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Andrey Biryulin, MD

Department of Medicine (Haemotology), St.John's Medical College Hospital
Bangalore, India
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Andrey Biryulin, MD

Narayana Hrudayalaya Hospitals
Bangalore, India
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Andrey Biryulin, MD

G.Kuppuswamy Naidu Memorial Hospital
Coimbatore, India
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Andrey Biryulin, MD

Medical Oncology Department, The Karnatak Cancer Therapy and Research Institute
Hubli, India
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Andrey Biryulin, MD

BIBI General hospital & cancer center
Hyderabad, India
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Andrey Biryulin, MD

Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Institute
Hyderabad, India
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Andrey Biryulin, MD

Omega Hospitals
Hyderabad, India
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Andrey Biryulin, MD

Department of Radiation Oncology, Meenakshi Mission Hospital & Research Centre
Madurai, India
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Andrey Biryulin, MD

Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russian Federation
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Andrey Biryulin, MD

City Hospital N8
Barnaul, Russian Federation
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Andrey Biryulin, MD

Municipal Institution "Central City Hospital 7"
Ekaterinburg, Russian Federation
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Andrey Biryulin, MD

Public health facility "Irkutsk Regional Oncology Center"
Irkutsk, Russian Federation
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Andrey Biryulin, MD

Ivanovo Regional Oncology Center
Ivanovo, Russian Federation
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Andrey Biryulin, MD

State Health Care Institution "Republican Clinical Cancer Center," the Ministry of Health of the Udmurt Republic
Izhevsk, Russian Federation
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Andrey Biryulin, MD

Public health facility "Kemerovo Regional Hospital"
Kemerovo, Russian Federation
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Andrey Biryulin, MD

Clinical Oncology Dispensary N1
Krasnodar, Russian Federation
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Andrey Biryulin, MD

Public health facility "Kursk Regional Cancer Center," Health Committee of Kursk region
Kursk, Russian Federation
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Andrey Biryulin, MD

Public health facility "Lipetsk Regional Oncology Center"
Lipetsk, Russian Federation
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Andrey Biryulin, MD

N.N. Burdenko General Military Clinical Hospital
Moscow, Russian Federation
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Andrey Biryulin, MD

Russian Medical Academy of Post-Graduate Education, Ministry of Health and Social Development of the Russian Federation
Moscow, Russian Federation
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Andrey Biryulin, MD

Research Center for Hematology MHSD RF
Moscow, Russian Federation
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Andrey Biryulin, MD

Official body of the health of the city of Moscow "Moscow City Clinical Hospital named after S. P. Botkin"
Moscow, Russian Federation
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Andrey Biryulin, MD

Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation
Obninsk, Russian Federation
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Andrey Biryulin, MD

Regional government health care "Oryol Regional Hospital"
Oryol, Russian Federation
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Andrey Biryulin, MD

Perm Region Oncology Dispensary
Perm, Russian Federation
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Andrey Biryulin, MD

V.A. Baranov Republican Hospital of Ministry of Health republic Karelia
Petrozavodsk, Russian Federation
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Andrey Biryulin, MD

Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation
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Andrey Biryulin, MD

Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
Saint Petersburg, Russian Federation
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Andrey Biryulin, MD

St. Petersburg State Health Care Institution "Alexander City Hospital"
Saint Petersburg, Russian Federation
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Andrey Biryulin, MD

Saint Petersburg City Clinical Oncology Center
Saint Petersburg, Russian Federation
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Andrey Biryulin, MD

Saint Petersburg Pavlov State Medical University
Saint Petersburg, Russian Federation
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Andrey Biryulin, MD

V.A. Almazov Federal Center for Heart, Blood and Endocrinology, Ministry of Health and Social Development of the Russian Federation
Saint Petersburg, Russian Federation
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Andrey Biryulin, MD

The federal government military educational institution of higher education, "Military Medical Academy named after SM Kirov's' Ministry of Defense"
Saint Petersurg, Russian Federation
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Andrey Biryulin, MD

Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"
Smolensk, Russian Federation
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Andrey Biryulin, MD

Oncology Dispensary 2
Sochi, Russian Federation
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Andrey Biryulin, MD

N.N.Petrov Oncology Research Center
St.Petersburg, Russian Federation
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Andrey Biryulin, MD

Russian scientific center of radiology and surgery technologies
St.Petersburg, Russian Federation
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Andrey Biryulin, MD

Tambov Regional Oncology Center
Tambov, Russian Federation
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Andrey Biryulin, MD

Municipal Health "Clinical Hospital 5" Togliatti
Togliatti, Russian Federation
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Andrey Biryulin, MD

Tula Regional Hospital
Tula, Russian Federation
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Andrey Biryulin, MD

Public health care setting of the Tyumen region "Regional Oncology Center"
Tyumen, Russian Federation
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Andrey Biryulin, MD

State Health Care Institution Republican Clinical Hospital named after G. G. Kuvatova
Ufa, Russian Federation
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Andrey Biryulin, MD

Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Ufa, Russian Federation
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Andrey Biryulin, MD

Volgograd District Oncology Dispensary 1
Volgograd, Russian Federation
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Andrey Biryulin, MD

The Medical Oncology Centre of Rosebank
Johannesburg, South Africa
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Andrey Biryulin, MD

Dr LS Fourie Oncology Practice
Pretoria, South Africa
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Andrey Biryulin, MD

Wits Clinical Research, Chris Hani Baragwanath Hospital
Soweto, South Africa
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Andrey Biryulin, MD

Medi-Clinic Vereeniging
Vereeniging, South Africa
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Andrey Biryulin, MD

Khmel'nyts'kyy Regional Hospital, Hematology Department
Khmel'nyts'kyy, Ukraine
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Andrey Biryulin, MD

National Institution of Cancer, Oncohematology Department
Kiev, Ukraine
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Andrey Biryulin, MD

State Institution "Institute of Blood Pathology and Transfusion Medicine AMS of Ukraine", Hematology Department
L'viv, Ukraine
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