Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma

It is planned to randomise approx. 312 subjects at approximately ≥ 130 study sites worldwide. Subjects with LTB-FL will be randomized to receive either DRL\_RI or MabThera®. Till date, 68 patients have been randomized for the study. The study specific objectives are mentioned below: Primary Objective: • To demonstrate the equivalent efficacy of DRL\_RI (biosimilar rituximab) and MabThera in subjects with CD20-positive, LTB FL, as measured by overall response rate (ORR) up to Week 28 evaluated in accordance with Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. Secondary Objectives: * To compare the progression-free survival (PFS), overall survival (OS), and duration of response (DOR) of DRL\_RI with MabThera® in subjects with CD20-positive, LTB FL. * To compare the safety, tolerability, and immunogenicity of DRL\_RI with MabThera in subjects with CD20-positive, LTB-FL. Exploratory Objectives * To explore the pharmacokinetic (PK) parameters of DRL\_RI and MabThera, using a population-PK modelling approach. * To explore the pharmacodynamic parameters of DRL\_RI and MabThera.