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.

Trial Profile

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.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2017

At a glance

  • Drugs Rituximab (Primary)
  • Indications Follicular lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ASSIST-FL
  • Sponsors HEXAL; Sandoz
  • Most Recent Events

    • 19 Jun 2017 According to a Sandoz media release, the European Commission (EC) has approved Rixathon (biosimilar rituximab) to treat the same indications as the reference product (MabThera). This approval is based on results from biosimilar development program that included this and ASSIST-RA trials.
    • 13 May 2017 This trial has been completed in Greece as per European Clinical Trials Database record.
    • 21 Apr 2017 According to a Sandoz media release, the Committee for Medicinal Products for Human Use (CHMP) of EMA has adopted positive opinion recommending approval of biosimilar rituximab to treat the same indications as the reference product (MabThera). The recommendation was based on results from biosimilar development program that included this and ASSIST-RA trials.
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