A phase 1/3, randomised, parallel-group, active-controlled, double-blind study to demonstrate equivalence of pharmacokinetics and noninferiority of efficacy for CT-P10 in comparison with Rituxan, each administered in combination with cyclophosphamide, vincristine, and prednisone (CVP) in patients with advanced follicular lymphoma

Trial Profile

A phase 1/3, randomised, parallel-group, active-controlled, double-blind study to demonstrate equivalence of pharmacokinetics and noninferiority of efficacy for CT-P10 in comparison with Rituxan, each administered in combination with cyclophosphamide, vincristine, and prednisone (CVP) in patients with advanced follicular lymphoma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Rituximab (Primary) ; Cyclophosphamide; Prednisone; Vincristine
  • Indications Follicular lymphoma
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Celltrion
  • Most Recent Events

    • 29 Jun 2017 According to a Celltrion media release, the BLA for CT-P10 has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected during the first quarter of 2018.
    • 29 Jun 2017 According to a Celltrion media release, based on the data from this and other trials the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P10 used to treat patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. Data from over 600 patients and 104 weeks supported BLA submission.
    • 25 Jun 2017 Results presented at the 22nd Congress of the European Haematology Association
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