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

PHASE3CompletedINTERVENTIONAL
Enrollment

317

Participants

Timeline

Start Date

May 15, 2019

Primary Completion Date

September 28, 2022

Study Completion Date

February 27, 2023

Conditions
Follicular Lymphoma
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

Trial Locations (4)

20817

American Oncology Partners of Maryland, Bethesda

37920

University of Tennessee Medical Center - Cancer Institute, Knoxville

77089

Gulf coast Oncology Associates, PA, Houston

90602

The Oncology Institute of Hope and Innovation, Whittier

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Dr. Reddy's Laboratories Limited

INDUSTRY