At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 629 enrolled
Drug / intervention
GP2013 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GP2013 and rituximab for Follicular Lymphoma. Completed, enrolled 629 participants across 153 sites in 26 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma
CountriesArgentina, 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
CollaboratorsNovartis Pharmaceuticals
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartDec 2011
Primary CompletionJul 2015
Study CompletionJan 2018
TodayJul 2026
First PostedAug 18, 2011
Enrollment StartDec 1, 2011
Primary CompletionJul 10, 2015
Study CompletionJan 22, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.9 years ago
Interventions
GP2013biological
Type: Biological/Vaccine
rituximabbiological
Type: Biological/Vaccine