Trials / Completed
CompletedNCT01701232
Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rituximab | Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22) |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2012-10-05
- Last updated
- 2017-11-06
Locations
62 sites across 5 countries: Colombia, India, Russia, South Africa, Ukraine
Source: ClinicalTrials.gov record NCT01701232. Inclusion in this directory is not an endorsement.