safety and efficacy study of bcd-020 in therapy of indolent non-hodgkin's lymphoma

Conditions: Follicular Non-Hodgkin's Lymphoma; Nodal Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma

Summary: 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.


Eligibility criteria:
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 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: * 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-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.

Keywords: lymphoma, non-hodgkin's