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 D

• Status: Recruiting
• Trial end date: 2022-08-31

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.

• Phase: Phase 2

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Acetaminophen; Cyclophosphamide; Diphenhydramine; Doxorubicin; Histamine Antagonists; Histamine H1 Antagonists; Prednisone; Promethazine; Rituximab; Vincristine