Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma
NCT ID: NCT01701232
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
174 participants
INTERVENTIONAL
2011-09-30
2017-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MabThera
Reference rituximab at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
rituximab
Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
BCD-020
Proposed rituximab biosimilar at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)
rituximab
Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
Interventions
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rituximab
Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients' age is 18 years or more;
* Diagnosis of CD20-positive indolent non-Hodgkin lymphoma of following morphological types:Follicular non-Hodgkin lymphoma stage II-IV according to Ann Arbor, grade I-II;Nodal marginal zone lymphoma stage II-IV according to Ann Arbor; Splenic marginal zone lymphoma.
* Life expectancy of not less than 3 months after the enrollment in the study;
* Morphological and immunohistochemical examination of the tumor (both lymph node biopsy and bone marrow biopsy) - within 3 months before the enrollment in the study ;
* Performance status ≤2 on the ECOG scale;
* Hemoglobin \> 80 g/l; leukocyte count ≥ 3.0×109/l but less than 25×109/l, absolute neutrophil count ≥1.5×109/l, platelet count ≥100×109/l;
* Presence of at least one measurable lesion;
* Patient's ability in the investigator's opinion to comply with the protocol procedures;
* Willingness of patients with preserved reproductive function to use reliable contraception methods (at least two contraception methods in women, e.g., spermicide and condom).
Exclusion Criteria
* Secondary transformation to high-grade lymphoma;
* Other types of non-Hodgkin lymphomas apart from follicular non-Hodgkin stage II-IV lymphoma according to Ann Arbor, grade 1,2; nodal marginal zone lymphoma stage II-IV according to Ann Arbor; splenic marginal zone lymphoma.
* Patients regularly taking corticosteroids during 1 month preceding the enrollment in the study;
* Occurrence of other (aside from NHL) diseases that can distort the assessment of the main disease symptoms expression; mask, enhance, modify the main disease symptoms or induce clinical and laboratory-instrumental symptoms similar to the non-Hodgkin lymphomas; Severe resistant hypertension; Decompensated forms of heart (NYHA class ХСН III, IV), liver and kidney disorders (creatinine level \>133 µmol/l, AST, ALT, and bilirubin level 3 times exceeding the norm) except for the cases where the symptom is caused by lymphoma; Decompensated respiratory failure; Tumor infiltration of the lungs; Decompensated diabetes mellitus; Active autoimmune diseases; Ongoing infections requiring antimicrobial therapy.
* Usage of the drugs:
At any time prior to the enrollment into the study - interferon-based drugs or monoclonal antibodies for the treatment of NHL; Chemotherapy or radiotherapy was completed less than 21 day prior to the enrollment into the study; Vaccination within 1 week prior to the enrollment into the study;
* Presence of any psychiatric disorders including major depressive conditions and/or suicidal thoughts in anamnesis that in opinion of the investigator may put a patient at an excessive risk or influence the ability of patients to fulfill the study protocol;
* Myocardial infarction less than 1 month before the enrollment into the study;
* Severe CNS or PNS dysfunctions;
* Drug and alcohol addiction;
* Known HIV, HBV, HCV infection, syphilis;
* Known primary or secondary immunodeficiency;
* Primary CNS lymphoma or metastasis in the CNS;
* Known intolerance or allergy to mouse proteins or any components of the study drugs, and also to the premedication drugs;
* Pregnancy or lactation;
* Prior or concomitant malignances except for adequately treated basal cell carcinoma and in situ cervical cancer;
* Any restraints or impossibility to administer the study drug via an intravenous infusion;
* Major surgery within 1 week prior to the enrollment into the study;
* Simultaneous participation in any other clinical study or any preceding participation in other studies within 3 months prior to enrollment in this study.
18 Years
95 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Roman Ivanov, PhD,MD
Role: STUDY_DIRECTOR
CJSC Biocad
Locations
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Instituto Nacional de Cancerología
Bogotá, , Colombia
Fundación Reina Isabel
Cali, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
HCG Multi Specialty Hospitals
Ahmedabad, , India
Department of Medical Oncology, Navneet Memorial Hospital, "Sushrusha"
Ahmedabad, , India
Sujan Surgicals
Amaravati, , India
HCG Bangalore Institute of Oncology
Bangalore, , India
Department of Medicine (Haemotology), St.John's Medical College Hospital
Bangalore, , India
Narayana Hrudayalaya Hospitals
Bangalore, , India
Srinivasam Cancer Care Hospital
Bangalore, , India
All India Institute of medical Sciences (AIIMS)
Bhubaneswar, , India
Acharya Tulasi Regional Cancer Treatment and Research Centre
Bikaner, , India
G.Kuppuswamy Naidu Memorial Hospital
Coimbatore, , India
Medical Oncology Department, The Karnatak Cancer Therapy and Research Institute
Hubli, , India
BIBI General hospital & cancer center
Hyderabad, , India
Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Institute
Hyderabad, , India
Omega Hospitals
Hyderabad, , India
Nilratan Siracar Medical College & Hospital
Kolkata, , India
King George Medical University
Lucknow, , India
Department of Radiation Oncology, Meenakshi Mission Hospital & Research Centre
Madurai, , India
Manas Super Speciality Hospital
Nashik, , India
City Cancer Center
Vijayawada, , India
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, , Russia
City Hospital N8
Barnaul, , Russia
Public health facility "Irkutsk Regional Oncology Center"
Irkutsk, , Russia
Ivanovo Regional Oncology Center
Ivanovo, , Russia
State Health Care Institution "Republican Clinical Cancer Center," the Ministry of Health of the Udmurt Republic
Izhevsk, , Russia
Public health facility "Kemerovo Regional Hospital"
Kemerovo, , Russia
Clinical Oncology Dispensary N1
Krasnodar, , Russia
Public health facility "Kursk Regional Cancer Center," Health Committee of Kursk region
Kursk, , Russia
Public health facility "Lipetsk Regional Oncology Center"
Lipetsk, , Russia
N.N. Burdenko General Military Clinical Hospital
Moscow, , Russia
Russian Medical Academy of Post-Graduate Education, Ministry of Health and Social Development of the Russian Federation
Moscow, , Russia
Research Center for Hematology MHSD RF
Moscow, , Russia
Official body of the health of the city of Moscow "Moscow City Clinical Hospital named after S. P. Botkin"
Moscow, , Russia
Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation
Obninsk, , Russia
Regional government health care "Oryol Regional Hospital"
Oryol, , Russia
Perm Region Oncology Dispensary
Perm, , Russia
V.A. Baranov Republican Hospital of Ministry of Health republic Karelia
Petrozavodsk, , Russia
Pyatigorsk Oncology Center
Pyatigorsk, , Russia
Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
Saint Petersburg, , Russia
St. Petersburg State Health Care Institution "Alexander City Hospital"
Saint Petersburg, , Russia
Saint Petersburg City Clinical Oncology Center
Saint Petersburg, , Russia
Saint Petersburg Pavlov State Medical University
Saint Petersburg, , Russia
V.A. Almazov Federal Center for Heart, Blood and Endocrinology, Ministry of Health and Social Development of the Russian Federation
Saint Petersburg, , Russia
N.N.Petrov Oncology Research Center
Saint Petersburg, , Russia
Russian scientific center of radiology and surgery technologies
Saint Petersburg, , Russia
The federal government military educational institution of higher education, "Military Medical Academy named after SM Kirov's' Ministry of Defense"
Saint Petersurg, , Russia
Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"
Smolensk, , Russia
Oncology Dispensary 2
Sochi, , Russia
Tambov Regional Oncology Center
Tambov, , Russia
Municipal Health "Clinical Hospital № 5" Togliatti
Tolyatti, , Russia
Tula Regional Hospital
Tula, , Russia
Public health care setting of the Tyumen region "Regional Oncology Center"
Tyumen, , Russia
State Health Care Institution Republican Clinical Hospital named after G. G. Kuvatova
Ufa, , Russia
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Ufa, , Russia
Volgograd District Oncology Dispensary №1
Volgograd, , Russia
Municipal Institution "Central City Hospital № 7"
Yekaterinburg, , Russia
Medi-Clinic Vereeniging
Vereeniging, , South Africa
Khmel'nyts'kyy Regional Hospital, Hematology Department
Khmelnytskyi, , Ukraine
National Cancer Institute of Ukraine, Oncohematology Department
Kiev, , Ukraine
State Institution "Institute of Blood Pathology and Transfusion Medicine AMS of Ukraine", Hematology Department
Lviv, , Ukraine
Countries
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Other Identifiers
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BIORIX (BCD-020-3)
Identifier Type: -
Identifier Source: org_study_id