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

Biocad

Status and phase

Completed

Phase 3

Conditions

Follicular Non-Hodgkin's Lymphoma

Nodal Marginal Zone Lymphoma

Splenic Marginal Zone Lymphoma

Treatments

Biological: rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01701232

BIORIX (BCD-020-3)

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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.