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)

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 24, 2021

Primary Completion Date

May 23, 2022

Study Completion Date

October 11, 2022

Conditions
Lymphoma, Large B-Cell, Diffuse
Interventions
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

Trial Locations (8)

100191

Peking University Third Hospital, Beijing

130021

The First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjing

330019

The 1st Affiliated Hospital of Nanchang Unversity, Nanchang

350014

Fujian Provincial Cancer Hospital, Fuzhou

430023

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

710061

The First Affiliated Hospital of Xian Jiao Tong University, Xi'an

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

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) | Biotech Hunter | Biotech Hunter