CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Rituximab IV +8 moredrug
Likely dose
Rituximab IV 375 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04660799
NCT04660799Phase 2Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Dec 9, 2020·Updated Oct 12, 2023

In Brief

A Phase 2 clinical trial evaluating Rituximab IV, Rituximab SC, and 6 other interventions for Lymphoma, Large B-Cell, Diffuse. Completed, enrolled 50 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Large B-Cell, Diffuse
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 9, 2020
Enrollment StartFeb 24, 2021
Primary CompletionMay 23, 2022
Study CompletionOct 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.6 years ago

Interventions

Rituximab IVdrug

Rituximab will be administered intravenously through Cycle 1-8 at a standard dose of 375 mg/m\^2 (milligram per square meter).

Rituximab SCdrug

Rituximab will be administered subcutaneously through Cycle 2-8 at a dose of 1400 milligram (mg).

Rituximab IVdrug

Rituximab will be administered intravenously in Cycle 1 at a standard dose of 375 mg/m\^2.

Cyclophosphamidedrug

Cyclophosphamide will be administered IV at a dose of 750 mg/m\^2

Doxorubicindrug

Doxorubicin will be administered IV at a dose of 50 mg/m\^2

Vincristinedrug

Vincristine will be administered IV at a dose of 1.4 mg/m\^2

Prednisonedrug

Prednisone will be administered orally at a dose of 100 mg/day

Paracetamoldrug

All participants are required to receive 1000 mg oral paracetamol as premedication prior to starting each infusion of rituximab

Diphenhydramine hydrochloride or alternative antihistaminedrug

All participants are required to receive 50-100 mg oral diphenhydramine hydrochloride or alternative antihistamine as premedication prior to starting each infusion of rituximab