drugset / Trial / NCT04361279

A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL

NCT04361279 ↗

Phase 3 Completed 421 enrolled Shanghai Institute Of Biological Products
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomised, double-blind, positive drug parallel controlled equivalence clinical trial initiated at about 30 sites in China. In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.

Timeline

Start
2019-07-25
Primary completion
2022-05-20
Completion
2022-05-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject SIBP-02 Unknown 375 mg/m2 Intravenous