MedTrace Logo

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

NCT03976102 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2024-01-22

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Eliso Sopia, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2022-09-28
Completion
2023-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976102 on ClinicalTrials.gov