drugset / Trial / NCT01205737

A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects

NCT01205737 ↗

Phase 1 Completed 186 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.

Timeline

Start
2010-09
Primary completion
2013-07
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject TL011 Unknown 375 mg/m2 Intravenous