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

NCT01701232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2017-11-06

No results posted yet for this study

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

  • Follicular Non-Hodgkin's Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma

Interventions

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)

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman Ivanov, PhD,MD · CJSC Biocad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Colombia
  • India
  • Russia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701232 on ClinicalTrials.gov