<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01701232</url>
  </required_header>
  <id_info>
    <org_study_id>BIORIX (BCD-020-3)</org_study_id>
    <nct_id>NCT01701232</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma</brief_title>
  <official_title>A Multicenter Open-label Randomized Study of BCD-020 (Rituximab, CJSC BIOCAD, Russia) Efficacy and Safety in Comparison With MabThera (F. Hoffmann-La Roche Ltd., Switzerland) in Monotherapy of CD20-positive Indolent Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biocad</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biocad</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This international multi-center, randomized, controlled, open-label study investigated the&#xD;
      pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: rituximab, CJSC&#xD;
      Biocad) versus MabThera® (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a&#xD;
      monotherapy of patients with indolent non-Hodgkin's lymphoma.&#xD;
&#xD;
      Patients were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for&#xD;
      4 weeks or MabThera® at the same regimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>day 50 (cycle 4)</time_frame>
    <description>Estimation of the overall response rate in each treatment arm at the end of treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CD20-positive cells count</measure>
    <time_frame>day 50</time_frame>
    <description>Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>day 22</time_frame>
    <description>Estimation of maximum rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-168)</measure>
    <time_frame>168 hours</time_frame>
    <description>Estimation of rituximab exposition after administration of BCD-020 to that obtained after administration of MabThera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>day 50</time_frame>
    <description>Assessment of complete response rates of BCD-020 and MabThera given as a monotherapy at the end/completion of the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of AEs/sAEs grade 3-4 (CTCAE v.4.03)</measure>
    <time_frame>day 50</time_frame>
    <description>Evaluation of the safety profiles of BCD-020 and MabThera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of binding and neutralizing antibodies to rituximab</measure>
    <time_frame>day 50</time_frame>
    <description>Immunogenicity assessment of BCD-020 and MabThera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-1176), AUC(0-inf)</measure>
    <time_frame>day 50</time_frame>
    <description>Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Follicular Non-Hodgkin's Lymphoma</condition>
  <condition>Nodal Marginal Zone Lymphoma</condition>
  <condition>Splenic Marginal Zone Lymphoma</condition>
  <arm_group>
    <arm_group_label>MabThera</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference rituximab at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BCD-020</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proposed rituximab biosimilar at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>rituximab</intervention_name>
    <description>Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)</description>
    <arm_group_label>BCD-020</arm_group_label>
    <arm_group_label>MabThera</arm_group_label>
    <other_name>Biological: BCD-020, MabThera</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having signed a written informed consent;&#xD;
&#xD;
          -  Patients' age is 18 years or more;&#xD;
&#xD;
          -  Diagnosis of CD20-positive indolent non-Hodgkin lymphoma of following morphological&#xD;
             types:Follicular non-Hodgkin lymphoma stage II-IV according to Ann Arbor, grade&#xD;
             I-II;Nodal marginal zone lymphoma stage II-IV according to Ann Arbor; Splenic marginal&#xD;
             zone lymphoma.&#xD;
&#xD;
          -  Life expectancy of not less than 3 months after the enrollment in the study;&#xD;
&#xD;
          -  Morphological and immunohistochemical examination of the tumor (both lymph node biopsy&#xD;
             and bone marrow biopsy) - within 3 months before the enrollment in the study ;&#xD;
&#xD;
          -  Performance status ≤2 on the ECOG scale;&#xD;
&#xD;
          -  Hemoglobin &gt; 80 g/l; leukocyte count ≥ 3.0×109/l but less than 25×109/l, absolute&#xD;
             neutrophil count ≥1.5×109/l, platelet count ≥100×109/l;&#xD;
&#xD;
          -  Presence of at least one measurable lesion;&#xD;
&#xD;
          -  Patient's ability in the investigator's opinion to comply with the protocol&#xD;
             procedures;&#xD;
&#xD;
          -  Willingness of patients with preserved reproductive function to use reliable&#xD;
             contraception methods (at least two contraception methods in women, e.g., spermicide&#xD;
             and condom).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bulky disease - size of any single lesion more than 10 cm in the greatest diameter;&#xD;
&#xD;
          -  Secondary transformation to high-grade lymphoma;&#xD;
&#xD;
          -  Other types of non-Hodgkin lymphomas apart from follicular non-Hodgkin stage II-IV&#xD;
             lymphoma according to Ann Arbor, grade 1,2; nodal marginal zone lymphoma stage II-IV&#xD;
             according to Ann Arbor; splenic marginal zone lymphoma.&#xD;
&#xD;
          -  Patients regularly taking corticosteroids during 1 month preceding the enrollment in&#xD;
             the study;&#xD;
&#xD;
          -  Occurrence of other (aside from NHL) diseases that can distort the assessment of the&#xD;
             main disease symptoms expression; mask, enhance, modify the main disease symptoms or&#xD;
             induce clinical and laboratory-instrumental symptoms similar to the non-Hodgkin&#xD;
             lymphomas; Severe resistant hypertension; Decompensated forms of heart (NYHA class ХСН&#xD;
             III, IV), liver and kidney disorders (creatinine level &gt;133 µmol/l, AST, ALT, and&#xD;
             bilirubin level 3 times exceeding the norm) except for the cases where the symptom is&#xD;
             caused by lymphoma; Decompensated respiratory failure; Tumor infiltration of the&#xD;
             lungs; Decompensated diabetes mellitus; Active autoimmune diseases; Ongoing infections&#xD;
             requiring antimicrobial therapy.&#xD;
&#xD;
          -  Usage of the drugs:&#xD;
&#xD;
        At any time prior to the enrollment into the study - interferon-based drugs or monoclonal&#xD;
        antibodies for the treatment of NHL; Chemotherapy or radiotherapy was completed less than&#xD;
        21 day prior to the enrollment into the study; Vaccination within 1 week prior to the&#xD;
        enrollment into the study;&#xD;
&#xD;
          -  Presence of any psychiatric disorders including major depressive conditions and/or&#xD;
             suicidal thoughts in anamnesis that in opinion of the investigator may put a patient&#xD;
             at an excessive risk or influence the ability of patients to fulfill the study&#xD;
             protocol;&#xD;
&#xD;
          -  Myocardial infarction less than 1 month before the enrollment into the study;&#xD;
&#xD;
          -  Severe CNS or PNS dysfunctions;&#xD;
&#xD;
          -  Drug and alcohol addiction;&#xD;
&#xD;
          -  Known HIV, HBV, HCV infection, syphilis;&#xD;
&#xD;
          -  Known primary or secondary immunodeficiency;&#xD;
&#xD;
          -  Primary CNS lymphoma or metastasis in the CNS;&#xD;
&#xD;
          -  Known intolerance or allergy to mouse proteins or any components of the study drugs,&#xD;
             and also to the premedication drugs;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Prior or concomitant malignances except for adequately treated basal cell carcinoma&#xD;
             and in situ cervical cancer;&#xD;
&#xD;
          -  Any restraints or impossibility to administer the study drug via an intravenous&#xD;
             infusion;&#xD;
&#xD;
          -  Major surgery within 1 week prior to the enrollment into the study;&#xD;
&#xD;
          -  Simultaneous participation in any other clinical study or any preceding participation&#xD;
             in other studies within 3 months prior to enrollment in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Ivanov, PhD,MD</last_name>
    <role>Study Director</role>
    <affiliation>CJSC Biocad</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerología</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Reina Isabel</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe</name>
      <address>
        <city>Medellín</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCG Multi Specialty Hospitals</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medical Oncology, Navneet Memorial Hospital, &quot;Sushrusha&quot;</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380009</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sujan Surgicals</name>
      <address>
        <city>Amaravati</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCG Bangalore Institute of Oncology</name>
      <address>
        <city>Bangalore</city>
        <zip>560027</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medicine (Haemotology), St.John's Medical College Hospital</name>
      <address>
        <city>Bangalore</city>
        <zip>560034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narayana Hrudayalaya Hospitals</name>
      <address>
        <city>Bangalore</city>
        <zip>560099</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Srinivasam Cancer Care Hospital</name>
      <address>
        <city>Bangalore</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of medical Sciences (AIIMS)</name>
      <address>
        <city>Bhubaneswar</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acharya Tulasi Regional Cancer Treatment and Research Centre</name>
      <address>
        <city>Bikaner</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G.Kuppuswamy Naidu Memorial Hospital</name>
      <address>
        <city>Coimbatore</city>
        <zip>641037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology Department, The Karnatak Cancer Therapy and Research Institute</name>
      <address>
        <city>Hubli</city>
        <zip>580025</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BIBI General hospital &amp; cancer center</name>
      <address>
        <city>Hyderabad</city>
        <zip>500024</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Institute</name>
      <address>
        <city>Hyderabad</city>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nilratan Siracar Medical College &amp; Hospital</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King George Medical University</name>
      <address>
        <city>Lucknow</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Radiation Oncology, Meenakshi Mission Hospital &amp; Research Centre</name>
      <address>
        <city>Madurai</city>
        <zip>625107</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manas Super Speciality Hospital</name>
      <address>
        <city>Nashik</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Cancer Center</name>
      <address>
        <city>Vijayawada</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkhangelsk District Clinical Oncology Dispensary</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital N8</name>
      <address>
        <city>Barnaul</city>
        <zip>656010</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution &quot;Central City Hospital № 7&quot;</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620137</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public health facility &quot;Irkutsk Regional Oncology Center&quot;</name>
      <address>
        <city>Irkutsk</city>
        <zip>664035</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivanovo Regional Oncology Center</name>
      <address>
        <city>Ivanovo</city>
        <zip>153013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Health Care Institution &quot;Republican Clinical Cancer Center,&quot; the Ministry of Health of the Udmurt Republic</name>
      <address>
        <city>Izhevsk</city>
        <zip>426009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public health facility &quot;Kemerovo Regional Hospital&quot;</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Oncology Dispensary N1</name>
      <address>
        <city>Krasnodar</city>
        <zip>350040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public health facility &quot;Kursk Regional Cancer Center,&quot; Health Committee of Kursk region</name>
      <address>
        <city>Kursk</city>
        <zip>305035</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public health facility &quot;Lipetsk Regional Oncology Center&quot;</name>
      <address>
        <city>Lipetsk</city>
        <zip>398005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N. Burdenko General Military Clinical Hospital</name>
      <address>
        <city>Moscow</city>
        <zip>105229</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Medical Academy of Post-Graduate Education, Ministry of Health and Social Development of the Russian Federation</name>
      <address>
        <city>Moscow</city>
        <zip>123995</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center for Hematology MHSD RF</name>
      <address>
        <city>Moscow</city>
        <zip>125167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Official body of the health of the city of Moscow &quot;Moscow City Clinical Hospital named after S. P. Botkin&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation</name>
      <address>
        <city>Obninsk</city>
        <zip>249036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional government health care &quot;Oryol Regional Hospital&quot;</name>
      <address>
        <city>Oryol</city>
        <zip>302028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perm Region Oncology Dispensary</name>
      <address>
        <city>Perm</city>
        <zip>614066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V.A. Baranov Republican Hospital of Ministry of Health republic Karelia</name>
      <address>
        <city>Petrozavodsk</city>
        <zip>185000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pyatigorsk Oncology Center</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Health Care Institution &quot;Alexander City Hospital&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>193312</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg City Clinical Oncology Center</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg Pavlov State Medical University</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V.A. Almazov Federal Center for Heart, Blood and Endocrinology, Ministry of Health and Social Development of the Russian Federation</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The federal government military educational institution of higher education, &quot;Military Medical Academy named after SM Kirov's' Ministry of Defense&quot;</name>
      <address>
        <city>Saint Petersurg</city>
        <zip>194044</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Provincial health official body &quot;Smolensk Regional Clinical Oncological Dispensary&quot;</name>
      <address>
        <city>Smolensk</city>
        <zip>214000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Dispensary 2</name>
      <address>
        <city>Sochi</city>
        <zip>354057</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N.Petrov Oncology Research Center</name>
      <address>
        <city>St.Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian scientific center of radiology and surgery technologies</name>
      <address>
        <city>St.Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tambov Regional Oncology Center</name>
      <address>
        <city>Tambov</city>
        <zip>390013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Health &quot;Clinical Hospital № 5&quot; Togliatti</name>
      <address>
        <city>Togliatti</city>
        <zip>445846</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tula Regional Hospital</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public health care setting of the Tyumen region &quot;Regional Oncology Center&quot;</name>
      <address>
        <city>Tyumen</city>
        <zip>625041</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Health Care Institution Republican Clinical Hospital named after G. G. Kuvatova</name>
      <address>
        <city>Ufa</city>
        <zip>450005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan</name>
      <address>
        <city>Ufa</city>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volgograd District Oncology Dispensary №1</name>
      <address>
        <city>Volgograd</city>
        <zip>400138</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medi-Clinic Vereeniging</name>
      <address>
        <city>Vereeniging</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khmel'nyts'kyy Regional Hospital, Hematology Department</name>
      <address>
        <city>Khmel'nyts'kyy</city>
        <zip>29000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute of Ukraine, Oncohematology Department</name>
      <address>
        <city>Kiev</city>
        <zip>03022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;Institute of Blood Pathology and Transfusion Medicine AMS of Ukraine&quot;, Hematology Department</name>
      <address>
        <city>L'viv</city>
        <zip>79044</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
    <country>India</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Ukraine</country>
  </location_countries>
  <removed_countries>
    <country>Belarus</country>
    <country>Brazil</country>
  </removed_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>November 2, 2017</last_update_submitted>
  <last_update_submitted_qc>November 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lymphoma, non-Hodgkin's</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell, Marginal Zone</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01701232
org study id: BIORIX (BCD-020-3)
nct id: NCT01701232
lead sponsor: 
has dmc: No
This international multi-center, randomized, controlled, open-label study investigated the
      pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: 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 were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for
      4 weeks or MabThera® at the same regimen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate
time frame: day 50 (cycle 4)
description: Estimation of the overall response rate in each treatment arm at the end of treatment
measure: CD20-positive cells count
time frame: day 50
description: Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration
measure: Cmax
time frame: day 22
description: Estimation of maximum rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera
measure: AUC(0-168)
time frame: 168 hours
description: Estimation of rituximab exposition after administration of BCD-020 to that obtained after administration of MabThera
measure: Complete response rate
time frame: day 50
description: Assessment of complete response rates of BCD-020 and MabThera given as a monotherapy at the end/completion of the treatment
measure: Frequency of AEs/sAEs grade 3-4 (CTCAE v.4.03)
time frame: day 50
description: Evaluation of the safety profiles of BCD-020 and MabThera
measure: Levels of binding and neutralizing antibodies to rituximab
time frame: day 50
description: Immunogenicity assessment of BCD-020 and MabThera
measure: AUC(0-1176), AUC(0-inf)
time frame: day 50
description: Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera
arm group label: MabThera
arm group type: Active Comparator
description: Reference rituximab at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
arm group label: BCD-020
arm group type: Experimental
description: Proposed rituximab biosimilar at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
intervention type: Biological
intervention name: rituximab
description: Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
arm group label: BCD-020
arm group label: MabThera
other name: Biological: BCD-020, MabThera
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Roman Ivanov, PhD,MD
role: Study Director
affiliation: CJSC Biocad
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Colombia
country: India
country: Russian Federation
country: South Africa
country: Ukraine
country: Belarus
country: Brazil
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell, Marginal Zone
mesh term: Lymphoma, Follicular
mesh term: Rituximab
sharing ipd: No