CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 572 enrolled
Drug / intervention
CHOP +2 moredrug
Likely dose
rituximab [MabThera/Rituxan] 375 mg/m2from 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/NCT01649856
NCT01649856Phase 3Completed
CompareCT.gov

A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

Hoffmann-La Roche·interventional·Posted Jul 25, 2012·Updated Oct 11, 2017

In Brief

A Phase 3 clinical trial evaluating CHOP and rituximab [MabThera/Rituxan] for Lymphoma, Large B-Cell, Diffuse. Completed, enrolled 572 participants across 186 sites in 27 countries.

Detailed Summary

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Large B-Cell, Diffuse
CountriesAlgeria, Argentina, Belgium, Brazil, Bulgaria, Canada, Colombia, Finland, France, Greece, Ireland, Israel, Italy, Netherlands, Peru, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2012
Enrollment StartAug 24, 2012
Primary CompletionOct 21, 2014
Study CompletionSep 16, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.9 years ago

Interventions

CHOPdrug

CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles

rituximab [MabThera/Rituxan]drug

The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles

rituximab [MabThera/Rituxan]drug

375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles