EU Clinical Trial 2018-004223-36

A Randomised, Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated, Stage II-IV, Cluster of Differentiation (CD)20-Positive, Low Tumour Burden Follicular Lymphoma  May 22, 2019

Main objective of the trial: The primary objective of the current study is to demonstrate the equivalent efficacy of DRL_RI and MabThera® in subjects with cluster of differentiation (CD)20-positive, low tumour burden follicular lymphoma (LTB-FL) in the first-line treatment setting, as measured by overall response rate (ORR). Demostrar la equivalencia de la eficacia de DRL_RI y MabThera® en sujetos con LTB-FL positivo para el antígeno CD20 de los linfocitos B, en su medición mediante la ORR , evaluada de acuerdo con los criterios de respuesta publicados para el linfoma maligno

Parties

Sponsors
Countries
BA BG BY CN CZ ES EU GE GR IN IT KR PL PT RO RS RU TH TR UA US
Keywords
Dr. Reddy’s rituximab Follicle centre lymphoma, follicular grade I, II, III stage IV MabThera RITUXIMAB

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Source:  EMA Last updated:  May 30, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.