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.

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2018

At a glance

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

    • 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.
    • 12 Sep 2017 Extended results of ASSIST-FL, a confirmatory phase III study presented at the 42nd European Society for Medical Oncology Congress
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