Health Condition 1: C859- Non-Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: BCD-020: (rituximab, CJSC BIOCAD, Russia) 375 mg/m2 once a week for 4 weeks by Intravenous Infusions.
Control Intervention1: MabThera®: (F. Hoffmann-La Roche Ltd.,
Switzerland) 375 mg/
Sponsors
Closed JointStock Company BIOCAD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Having signed a written informed consent 2. Patients age is 18 years or more 3. 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. 4. Life expectancy of not less than 3 months after the enrollment in the study 5. Morphological and immunohistochemical examination of the tumor (both lymph node biopsy and bone marrow biopsy) â?? within 3 months before the enrollment in the study 6. Performance status 7. Hemoglobin > 80 g/l; leukocyte count >= 3.0Ã?10 9/l but less than 25Ã?109/l, absolute neutrophil count >=1.5Ã?10 9/l, platelet count >=100Ã?10 9/l 8. Presence of at least one measurable lesion 9. Patient ability in the investigator opinion to comply with the protocol procedures 10. 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
Exclusion criteria: 1. Bulky disease â?? size of any single lesion more than 10 cm in the greatest diameter; 2. Secondary transformation to high-grade lymphoma; 3. 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. 4. Patients regularly taking corticosteroids during 1 month preceding the enrollment in the study; 5. 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 ХСÐ? 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. 6. 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; 7. 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; 8. Myocardial infarction less than 1 month before the enrollment into the study; 9. Severe CNS or PNS dysfunctions; 10. Drug and alcohol addiction; 11. Known HIV, HBV, HCV infection, syphilis; 12. Known primary or secondary immunodeficiency; 13. Primary CNS lymphoma or metastasis in the CNS; 14. Known intolerance or allergy to mouse proteins or any components of the study drugs, and also to the premedication drugs; 15. Pregnancy or lactation; 16. Prior or concomitant malignances except for adequately treated basal cell carcinoma and in situ cervical cancer; 17. Any restraints or impossibility to administer the study drug via an intravenous infusion; 18. Major surgery within 1 week prior to the enrollment into the study; 19. Simultaneous participation in any other clinical study or any preceding participation in other studies within 3 months prior to enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of CD20+ lymphocytes in the peripheral bloodTimepoint: immediately prior to the first infusion of BCD-020 or MabThera®, 24, 48, 72 hours after the infusion and before subsequent infusion on day 8, 15 and 22 Overall response rate on day 50±5 after the start of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The Blood serum concentration of rituximabTimepoint: immediately prior to the first infusion of BCD-020 or MabThera®, 24, 48, 72 hours after the infusion and before subsequent infusion on day 8, 15 and 22 Overall response rate on day 50±5 after the start of the treatment | — |
Countries
India, Russian Federation, Ukraine
Contacts
Public ContactDr Girish Gowda
SMO Clinical Research (I) Pvt. Ltd.,
Outcome results
None listed