A Randomised, Multi-centre, Double-blind, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Two Anti-CD20 Monoclonal Antibodies in Combination with CHOP in Patients with CD20-Positive Diffuse Large B-cell Lymphoma

Trial Profile

A Randomised, Multi-centre, Double-blind, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Two Anti-CD20 Monoclonal Antibodies in Combination with CHOP in Patients with CD20-Positive Diffuse Large B-cell Lymphoma

Recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Jun 2017

At a glance

  • Drugs Rituximab (Primary) ; Cyclophosphamide; Doxorubicin; Prednisolone; Vincristine
  • Indications Diffuse large B cell lymphoma
  • Focus Pharmacokinetics
  • Sponsors Dr Reddys Laboratories
  • Most Recent Events

    • 06 Jun 2017 Primary endpoint (To evaluate the PK equivalence of two anti CD-20 antibodies [DRL-rituximab(Reditux)and MabThera]) has been met as per the results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 06 Jun 2017 Results (n=151) presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 06 Dec 2016 Results (n=151) from cycle 1 of the study assessing safety, pharmacokinetics and pharmacodynamics, presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
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