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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)

NCT04660799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-12

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2022-05-23
Completion
2022-10-11
FDA Drug
Yes

Countries

  • China

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04660799 on ClinicalTrials.gov