NCT03976102

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

A 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 (CD)20-Positive LTB Follicular Lymphoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL). Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity. The study will compare the safety and efficacy of DRL\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28

Detailed description

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.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	DRL_RI (Proposed rituximab biosimilar)	Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion
OTHER	MabThera®	Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion

Timeline

• Start date: 2019-05-15
• Primary completion: 2022-09-28
• Completion: 2023-02-27
• First posted: 2019-06-05
• Last updated: 2024-01-22
• Results posted: 2024-01-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study