A randomized, controlled, double-blind Phase III trial to compare the efficacy, safety and pharmacokinetics of GP2013 plus Cyclophosphamide, Vincristine, Prednisone vs. MabThera plus Cyclophosphamide, Vincristine, Prednisone, followed by GP2013 or MabThera maintenance therapy in patients with previously untreated, advanced stage follicular lymphoma.
Phase of Trial: Phase III
Latest Information Update: 24 Jul 2018
At a glance
- Drugs Rituximab (Primary)
- Indications Follicular lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms ASSIST-FL
- Sponsors HEXAL; Sandoz
- 02 May 2018 According to a Sandoz media release, the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.
- 12 Feb 2018 Status changed from active, no longer recruiting to completed.
- 09 Feb 2018 This study has been completed in Spain as per European Clinical Trials Database.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History