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
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 µµmol/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.