A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Summary

This is a multicenter China-only study to investigate the PK, efficacy and safety of SC rituximab versus IV rituximab, both in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated participants with CD20 positive DLBCL. Participants will be randomized to receive eight cycles of rituximab SC or rituximab IV combined with six or eight cycles of standard CHOP chemotherapy. After the end of study treatment, participants will be followed-up every 3 months for 6 months.

Timeline

Start

2021-02-24

Primary completion

2022-05-23

Completion

2022-10-11

Publications

• Gao Y, Zhang L, Gao S, Yang Y, Zhang Q, Zhang H, He P, Li F, Jing H, Grange S, Bu L, Wang Q, Li L, Huang H. Pharmacokinetics, efficacy, and safety of subcutaneous versus intravenous rituximab in previously untreated Chinese patients with CD20+ diffuse large B-cell lymphoma: a phase II randomized controlled trial. Leuk Lymphoma. 2025 Apr;66(4):680-690. doi: 10.1080/10428194.2024.2439525. Epub 2025 Jan 7.

Drugs

Indications