A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma

Summary

This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.

Timeline

Start

2017-01-18

Primary completion

2019-07-17

Completion

2020-01-10

Outcome

Missed primary endpoint

registry analysis (other test); SAIT101 vs MabThera; Adjusted Difference Rate (%) -4.2 (95% CI -14.80 to 6.35) NCT02809053 ↗

Drugs

Indications