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

Study Director: Carina Flemmig, MD, Parexel

Description: In a randomized, phase 3 trial, researchers will compare a proposed rituximab biosimilar (DRL_RI) with the rituximab originator (MabThera) in patients with previously untreated, CD20-postive, low tumor burden follicular lymphoma (FL).


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Participants will receive either DRL_RI or MabThera at 375 mg/m2 administered via IV infusion on days 1, 8, 15, and 22 and weeks 12, 20, 28, and 36.

The primary outcome measure is overall response rate. Secondary endpoints include progression-free survival, overall survival, response duration, safety, tolerability, and immunogenicity.

To be eligible for the study, patients must have previously untreated, CD20-positive, grade 1-3a FL. They must be 18 years of age or older and have a performance status of 0 to 1. For a complete list of eligibility criteria, please refer to the reference.

Status: Recruiting

This study is sponsored by Dr. Reddy’s Laboratories Limited and Parexel.

Reference

Clinicaltrials.gov. Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma (FLINTER). NCT03976102. Accessed October 20, 2021.