CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 743 enrolled
Drug / intervention
Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP) +6 moredrug
Likely dose
Rituximab 1400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01724021
NCT01724021Phase 3Completed
CompareCT.gov

A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2, OR 3A

Hoffmann-La Roche·interventional·Posted Nov 9, 2012·Updated Jan 23, 2018

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP), Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP), and 2 other interventions for Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma. Completed, enrolled 743 participants across 246 sites in 32 countries.

Detailed Summary

This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
CountriesArgentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Italy, Malaysia, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, South Korea, Sweden, Taiwan, Thailand, Turkey (Türkiye), Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2012
Enrollment StartDec 1, 2012
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.6 years ago

Interventions

Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)drug

Standard chemotherapy

Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)drug

Standard chemotherapy

Bendamustinedrug

Standard chemotherapy

Rituximabdrug

1400 mg subcutaneously (SC), Day 1 Cycles 2-4

Rituximabdrug

375 mg/m2 IV, Day 1 Cycles 1-4

Rituximabdrug

375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8

Rituximabdrug

1400 mg SC, Day 1 Cycles 5-8