drugset / Trial / NCT04361279
A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | SIBP-02 | Unknown | 375 mg/m2 | Intravenous |