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: 12 Sep 2017

At a glance

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

    • 12 Sep 2017 Extended results of ASSIST-FL, a confirmatory phase III study presented at the 42nd European Society for Medical Oncology Congress
    • 12 Sep 2017 Interpretation of survival data with a sensitivity analysis from this trial presented at the 42nd European Society for Medical Oncology Congress
    • 12 Sep 2017 According to a Sandoz media release, The US FDA accepted Biologics License Application (BLA) under the 351(k) pathway for a proposed biosimilar to the reference medicine, rituximab (Rituxan).This submission is based on data from ASSIST-RA and ASSIST-FL studies.
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