drugset / Trial / NCT01205737
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | TL011 | Unknown | 375 mg/m2 | Intravenous |