Trials / Completed
CompletedNCT01205737
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 186 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TL011 | 375 mg/m2 iv every 3 weeks for 8 cycles |
| BIOLOGICAL | Rituximab | 375 mg/m2 iv every 3 weeks for 8 cycles |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2013-07-01
- Completion
- 2013-09-01
- First posted
- 2010-09-20
- Last updated
- 2013-10-22
Locations
41 sites across 10 countries: Bulgaria, Estonia, France, Hungary, Italy, Latvia, Poland, Russia, Spain, Ukraine
Source: ClinicalTrials.gov record NCT01205737. Inclusion in this directory is not an endorsement.