Trials / Completed
CompletedNCT01419665
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 629 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GP2013 | Type: Biological/Vaccine |
| BIOLOGICAL | rituximab | Type: Biological/Vaccine |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2015-07-10
- Completion
- 2018-01-22
- First posted
- 2011-08-18
- Last updated
- 2021-05-14
- Results posted
- 2021-05-14
Locations
153 sites across 26 countries: Argentina, Australia, Austria, Brazil, Bulgaria, Colombia, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Peru, Poland, Portugal, Romania, Russia, South Africa, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01419665. Inclusion in this directory is not an endorsement.