A Phase 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 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: 06 Apr 2018

At a glance

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

    • 06 Apr 2018 According to a Celltrion media release,Celltrion received a Complete Response Letters (CRLs) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for CT-P10 (rituximab)
    • 12 Dec 2017 Results of pharmacokinetic post-hoc analysis (n=121) comparing pharmacokinetic data between CT-P10 and Rituxan with different subgroups in advanced-stage follicular lymphoma patients, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 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.
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