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

Inclusion Criteria:

• Having signed a written informed consent;

• Patients' age is 18 years or more;

• Diagnosis of CD20-positive indolent non-Hodgkin lymphoma of following morphologicaltypes:Follicular non-Hodgkin lymphoma stage II-IV according to Ann Arbor, gradeI-II;Nodal marginal zone lymphoma stage II-IV according to Ann Arbor; Splenic marginalzone 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 biopsyand 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, absoluteneutrophil 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 protocolprocedures;

• Willingness of patients with preserved reproductive function to use reliablecontraception methods (at least two contraception methods in women, e.g., spermicideand condom).

Exclusion Criteria:

• Bulky disease - size of any single lesion more than 10 cm in the greatest diameter;

• Secondary transformation to high-grade lymphoma;

• Other types of non-Hodgkin lymphomas apart from follicular non-Hodgkin stage II-IVlymphoma according to Ann Arbor, grade 1,2; nodal marginal zone lymphoma stage II-IVaccording to Ann Arbor; splenic marginal zone lymphoma.

• Patients regularly taking corticosteroids during 1 month preceding the enrollment inthe study;

• Occurrence of other (aside from NHL) diseases that can distort the assessment of themain disease symptoms expression; mask, enhance, modify the main disease symptoms orinduce clinical and laboratory-instrumental symptoms similar to the non-Hodgkinlymphomas; Severe resistant hypertension; Decompensated forms of heart (NYHA class ХСНIII, IV), liver and kidney disorders (creatinine level >133 µmol/l, AST, ALT, andbilirubin level 3 times exceeding the norm) except for the cases where the symptom iscaused by lymphoma; Decompensated respiratory failure; Tumor infiltration of thelungs; Decompensated diabetes mellitus; Active autoimmune diseases; Ongoing infectionsrequiring antimicrobial therapy.

• Usage of the drugs: At any time prior to the enrollment into the study - interferon-based drugs or monoclonalantibodies 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 theenrollment into the study;

• Presence of any psychiatric disorders including major depressive conditions and/orsuicidal thoughts in anamnesis that in opinion of the investigator may put a patientat an excessive risk or influence the ability of patients to fulfill the studyprotocol;

• 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 carcinomaand in situ cervical cancer;

• Any restraints or impossibility to administer the study drug via an intravenousinfusion;

• Major surgery within 1 week prior to the enrollment into the study;

• Simultaneous participation in any other clinical study or any preceding participationin other studies within 3 months prior to enrollment in this study.