NCT04660799

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)

A Phase II Comparative, Open-Label, Randomized, Multicenter, China-Only Study to Investigate the Pharmacokinetics, Efficacy and Safety of Subcutaneous Rituximab Versus Intravenous Rituximab Both in Combination With CHOP in Previously Untreated Patients With CD20 Positive Diffuse Large B Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	Rituximab IV	Rituximab will be administered intravenously through Cycle 1-8 at a standard dose of 375 mg/m\^2 (milligram per square meter).
DRUG	Rituximab SC	Rituximab will be administered subcutaneously through Cycle 2-8 at a dose of 1400 milligram (mg).
DRUG	Rituximab IV	Rituximab will be administered intravenously in Cycle 1 at a standard dose of 375 mg/m\^2.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered IV at a dose of 750 mg/m\^2
DRUG	Doxorubicin	Doxorubicin will be administered IV at a dose of 50 mg/m\^2
DRUG	Vincristine	Vincristine will be administered IV at a dose of 1.4 mg/m\^2
DRUG	Prednisone	Prednisone will be administered orally at a dose of 100 mg/day
DRUG	Paracetamol	All participants are required to receive 1000 mg oral paracetamol as premedication prior to starting each infusion of rituximab
DRUG	Diphenhydramine hydrochloride or alternative antihistamine	All participants are required to receive 50-100 mg oral diphenhydramine hydrochloride or alternative antihistamine as premedication prior to starting each infusion of rituximab

Timeline

• Start date: 2021-02-24
• Primary completion: 2022-05-23
• Completion: 2022-10-11
• First posted: 2020-12-09
• Last updated: 2023-10-12
• Results posted: 2023-07-27

Locations

8 sites across 1 country: China

Regulatory

• FDA-regulated drug study