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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
Overall response rate
Estimation of the overall response rate in each treatment arm at the end of treatment
Time frame: day 50 (cycle 4)
CD20-positive cells count
Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration
Time frame: day 50
Cmax
Estimation of maximum rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera
Time frame: day 22
AUC(0-168)
Estimation of rituximab exposition after administration of BCD-020 to that obtained after administration of MabThera
Time frame: 168 hours
Complete response rate
Assessment of complete response rates of BCD-020 and MabThera given as a monotherapy at the end/completion of the treatment
Time frame: day 50
Frequency of AEs/sAEs grade 3-4 (CTCAE v.4.03)
Evaluation of the safety profiles of BCD-020 and MabThera
Time frame: day 50
Levels of binding and neutralizing antibodies to rituximab
Immunogenicity assessment of BCD-020 and MabThera
Time frame: day 50
AUC(0-1176), AUC(0-inf)
Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera
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Instituto Nacional de Cancerología
Bogotá, Colombia
Fundación Reina Isabel
Cali, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
HCG Multi Specialty Hospitals
Ahmedabad, India
Department of Medical Oncology, Navneet Memorial Hospital, "Sushrusha"
Ahmedabad, India
Sujan Surgicals
Amaravati, India
HCG Bangalore Institute of Oncology
Bangalore, India
Department of Medicine (Haemotology), St.John's Medical College Hospital
Bangalore, India
Narayana Hrudayalaya Hospitals
Bangalore, India
Srinivasam Cancer Care Hospital
Bangalore, India
...and 52 more locations
Time frame: day 50